DR

OTC products · Product label record

DRX CHOICE Regular Strength drug information

ACETAMINOPHEN
Raritan Pharmaceuticals Inc. · ORAL

Product NDC: 68163-065

Join the community
CommunityExperiencesReviewsDrug database
Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameACETAMINOPHEN
Labeler / manufacturerRaritan Pharmaceuticals Inc.
RouteORAL
Drug classDrug class not supplied in source label
Product NDC68163-065
Label effective date2026-09-05

Official product label reference

DRX CHOICE Regular Strength — Raritan Pharmaceuticals Inc.

This page contains 15 source sections for ACETAMINOPHEN, oral route. Label set 8bacb24a-24d0-4175-b3e0-05efb5f5d373, version 2.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses • temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • the common cold • toothache • premenstrual and menstrual cramps • temporarily reduces fever

Purpose

Purpose Pain reliever/fever reducer
Dosage and administration — label text
Directions ▪ do not take more than directed (see overdose warning ) adults and children 12 years and over • take 2 tablets every 4 to 6 hours while symptoms last • do not take more than 10 tablets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years • take 1 tablet every 4 to 6 hours while symptoms last • do not take more than 5 tablets in 24 hours • do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor Table text from source: | adults and children 12 years and over | •take 2 tablets every 4 to 6 hours while symptoms last•do not take more than 10 tablets in 24 hours, unless directed by a doctor•do not use for more than 10 days unless directed by a doctor | children 6 years to under 12 years | •take 1 tablet every 4 to 6 hours while symptoms last•do not take more than 5 tablets in 24 hours•do not use for more than 5 days unless directed by a doctor | children under 6 years | ask a doctor
Warnings
Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if the user • has liver disease • is a child with pain of arthritis Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if • pain gets worse or lasts more than 10 days in adults • pain gets worse or lasts more than 5 days in children under 12 years • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Unclassified section
Drug Facts
Active ingredient
Active ingredient (in each tablet) Acetaminophen 325 mg
Do not use
Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use
Ask a doctor before use if the user • has liver disease • is a child with pain of arthritis
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
When to stop use and seek help
Stop use and ask a doctor if • pain gets worse or lasts more than 10 days in adults • pain gets worse or lasts more than 5 days in children under 12 years • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children.
Storage and handling
Other information • store at room temperature.
Inactive ingredient
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinyl pyrrolidone, pregelatinized starch, stearic acid powder, talc, titanium dioxide
Questions
Questions? 1-866-467-2748

Official sources and product identifiers

Substances listed: ACETAMINOPHEN

RxNorm identifiers: 313782

Package NDC codes

68163-065-60

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.