On this page

Orphenadrine Citrate, Aspirin and Caffeine

Prescription ANDA Official labelling

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Orphenadrine Citrate, Aspirin and Caffeine

Generic name

Orphenadrine Citrate, Aspirin and Caffeine

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Atland Pharmaceuticals, LLC

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Aspirin	385 mg/1	994535	View
Aspirin	770 mg/1	994535	View
Caffeine	30 mg/1	994535	View
Caffeine	60 mg/1	994535	View
Orphenadrine Citrate	25 mg/1	994535	View
Orphenadrine Citrate	50 mg/1	994535	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Anti-Inflammatory Agents	EPC	All 251 members
Central Nervous System Stimulant [EPC]	EPC	All 93 members
Central Nervous System Stimulation [PE]	PE	All 95 members
Centrally-mediated Muscle Relaxation [PE]	PE	All 22 members
Cyclooxygenase Inhibitors [MoA]	MoA	All 251 members
Decreased Platelet Aggregation [PE]	PE	All 39 members
Decreased Prostaglandin Production [PE]	PE	All 54 members
Methylxanthine [EPC]	EPC	All 30 members
Muscle Relaxant [EPC]	EPC	All 22 members
Non-Steroidal [CS]	CS	All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC]	EPC	All 251 members
Platelet Aggregation Inhibitor [EPC]	EPC	All 29 members
Xanthines [CS]	CS	All 30 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

075141

Application type

ANDA · Abbreviated New Drug Application

Approval date

May 29, 1998

Sponsor

GALT PHARMS

Products on application

Submissions recorded

Products approved under application 075141.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
075141-001	ORPHENGESIC	TABLET		ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	Prescription	—
075141-002	ORPHENGESIC FORTE	TABLET		ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	Prescription	—	RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 075141.
Type	No.	Action	Status	Date	Review
Supplement	4	Labeling	Approved	November 21, 2024	Standard
Supplement	2	Labeling	Approved	April 28, 2021	Standard
Original application	1		Approved	May 29, 1998	—

Review documents

0 · Original application · May 29, 1998

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251017). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20251017 HUMAN PRESCRIPTION DRUG · 20251016

Indications and Usage

openFDA Drug Labeling

INDICATIONS & USAGE Orphenadrine Citrate, Aspirin and Caffeine 25 mg/ 385 mg/ 30 mg Tablets are indicated in: Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine Citrate, Aspirin and Caffeine Tablets do not directly relax tense muscles in man.

Dosage and Administration

openFDA Drug Labeling

DOSAGE & ADMINISTRATION Orphenadrine Citrate, Aspirin and Caffeine Tablets: Adults 1/2 to 1 tablet 3 to 4 times daily.

Contraindications

openFDA Drug Labeling

CONTRAINDICATIONS Because of the mild anticholinergic effect of orphenadrine, Orphenadrine Citrate, Aspirin and Caffeine Tablets should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. Orphenadrine Citrate, Aspirin and Caffeine Tablets are also contraindicated in patients with myasthenia gravis and in patients known to be sensitive to aspirin or caffeine. The drug is contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

Warnings

openFDA Drug Labeling

WARNINGS Reye’s Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest possible association between the development of Reye’s Syndrome and the use of medicines containing salicylate or aspirin. Orphenadrine Citrate, Aspirin and Caffeine Tablets 25 mg/ 385 mg/ 30 mg contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms. Orphenadrine Citrate, Aspirin and Caffeine Tablets may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly. Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation abnormalities. Pregnancy Risk Summary Use of NSAIDs, including aspirin, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of Orphenadrine Citrate, Aspirin and Caffeine Tablets use between about 20 and 30 weeks of gestation, and avoid Orphenadrine Citrate, Aspirin and Caffeine Tablets use at about 30 weeks of gestation and later in pregnancy [ see WARNINGS; Fetal Toxicity ]. Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including aspirin, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as aspirin, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including Orphenadrine Citrate, Aspirin and Caffeine Tablets, can cause premature closure of the fetal ductus arteriosus (see WARNINGS; Fetal Toxicity ) . Oligohydramnios/Neonatal Renal Impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If Orphenadrine Citrate, Aspirin and Caffeine Tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue Orphenadrine Citrate, Aspirin and Caffeine Tablets and follow up according to clinical practice (see WARNINGS; Fetal Toxicity ) . Data Human Data Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published studi …

Adverse Reactions

openFDA Drug Labeling

ADVERSE REACTIONS Side effects of Orphenadrine Citrate, Aspirin and Caffeine Tablets are those seen with aspirin and caffeine or those usually associated with mild anti-cholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatosis. Infrequently, an elderly patient may experience some degree of confusion. Mild central excitation and occasional hallucinations may be observed. These mild side effects can usually be eliminated by reduction in dosage. One case of aplastic anemia associated with the use of orphenadrine citrate, aspirin and caffeine has been reported. No causal relationship has been established. Rare G.I. hemorrhage due to aspirin content may be associated with the administration of Orphenadrine Citrate, Aspirin and Caffeine Tablets. Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine Citrate, Aspirin and Caffeine Tablets may also cause exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrosis (TEN), and fixed drug eruption (FDE) ( see WARNINGS ).

Description

openFDA Drug Labeling

DESCRIPTION Each Orphenadrine Citrate, Aspirin and Caffeine Tablet, for oral administration contains Orphenadrine Citrate 50 mg, Aspirin 770 mg and Caffeine 60 mg. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, zinc stearate, povidone, pregelatinized starch, and stearic acid. Orphenadrine citrate is (2-dimethylaminoethyl 2-methylbenzhydryl ether citrate). It is a white, practically odorless, crystalline powder, having a bitter taste. It is sparingly soluble in water; slightly soluble in alcohol. It has the following structural formula: Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent It occurs as a white, crystalline tabular or needle-like powder and is odorless or has a faint odor. It is sparingly soluble in water, freely soluble in alcohol and chloroform. It has the following structural formula: Caffeine is a central nervous system stimulant which occurs as a white powder or white glistening needles, usually matted together. It is sparingly soluble in alcohol, and freely soluble in chloroform. The chemical name for caffeine is, 1,3,7-Trimethylxanthine. It has the following structural formula: Structure1 Structure2 Structure3

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Orphenadrine Citrate, Aspirin, and Caffeine Tablets (Orphenadrine Citrate 25 mg, Aspirin 385 mg, and Caffeine 30 mg): Two-layered, white/green round flat faced beveled edge tablet debossed “OAC” over “472” on the white side and plain on the green side. They are available in bottles of 60 tablets (NDC 71993-304-60). Store below 30°C (86°F) Rx Only Manufactured for: ATLAND Pharmaceuticals, LLC Sylacauga, AL 35150 201132-01 Rev. 09/2025

Adverse event reports

Source: openFDA FAERS

560,678

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ASPIRIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
71993-304-60	71993-304	Atland Pharmaceuticals, LLC	60 TABLET in 1 BOTTLE, PLASTIC (71993-304-60)	March 18, 2022
71993-307-60	71993-307	Atland Pharmaceuticals, LLC	60 TABLET in 1 BOTTLE, PLASTIC (71993-307-60)	March 1, 2023
71993-304	71993-304	Atland Pharmaceuticals, LLC	—	March 18, 2022
71993-307	71993-307	Atland Pharmaceuticals, LLC	—	March 1, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.