OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen tablet
CVS PHARMACY, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

(in each Gelcap)

Acetaminophen, USP 500 mg

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ toothache

■ he common cold

■ premenstrual and menstrual cramps

■ temporarily reduces fever

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days

■ 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 the reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

■ do not take more than directed

adults and children 12 years and over

■ take 2 gelcaps every 6 hours while symptoms last

■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor

■ do not take more than 10 days unless directed by a doctor

children under 12 years

■ ask a doctor

Other information

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature

■ avoid high humidity

■ see end panel for lot number and expiration date

Inactive ingredients

ammonium hydroxide, black iron oxide, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

Acetaminophen, USP 500 mg Rapid Release Gelcaps

300 count
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225 count
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100 count
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50 count
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24 count
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150 count
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600 count
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80 count
(click image for full-size original)

ACETAMINOPHEN
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-298
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
GELATIN
FERRIC OXIDE RED
POLYETHYLENE GLYCOL, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)
FERROSOFERRIC OXIDE
SILICON DIOXIDE
HYPROMELLOSES
BUTYL ALCOHOL
POVIDONE
STARCH, PREGELATINIZED CORN
STEARIC ACID
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color gray (Encapsulated with red opaque and blue gray opaque hard gelatin shells) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code G1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-298-24 24 TABLET in 1 BOTTLE None
2 NDC:69842-298-05 50 TABLET in 1 BOTTLE None
3 NDC:69842-298-10 100 TABLET in 1 BOTTLE None
4 NDC:69842-298-21 225 TABLET in 1 BOTTLE None
5 NDC:69842-298-30 300 TABLET in 1 BOTTLE None
6 NDC:69842-298-40 400 TABLET in 1 BOTTLE None
7 NDC:69842-298-60 600 TABLET in 1 BOTTLE None
8 NDC:69842-298-15 150 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 04/01/2019
Labeler — CVS PHARMACY, INC (062312574)

Revised: 03/2023 CVS PHARMACY, INC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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