OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen tablet
MEIJER, INC.

Active ingredient (in each caplet)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 6 caplets in 24 hours, which is the maximum daily amount
■ 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 are allergic to acetaminophen or any of the inactive ingredients in this product

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 reach of children.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (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.

Directions

do not take more than directed (see overdose warning)

adults and children ■ take 2 caplets every 8 hours with water
■ swallow whole; do not crush, chew, split or dissolve
■ do not take more than 6 caplets in 24 hours
■ do not use for more than 10 days unless directed by a doctor 12 years of age and over

children under 12 years ■ do not use

Other information

■ store between 20-25°C (68-77°F) ■ do not use if foil inner seal is broken or missing

Inactive ingredients

hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

PDP

APAP 650mg 100ct
(click image for full-size original)
APAP 650mg 24ct
(click image for full-size original)

ACETAMINOPHEN acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0184
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A CORN
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
STARCH, CORN
POLYETHYLENE GLYCOL 400
POVIDONE K30
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G650
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79481-0184-8 24 TABLET in 1 BOTTLE None
2 NDC:79481-0184-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211544 07/17/2023
Labeler — MEIJER, INC. (006959555)

Revised: 12/2023 MEIJER, 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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