ACETAMINOPHEN ACETAMINOPHEN GERI-CARE PHARMACEUTICAL CORP FDA Approved USES • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
ANDA211544
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT (IN EACH CAPLET) Acetaminophen 650 mg
Inactive Ingredients
INACTIVE INGREDIENTS hydroxyethyl cellulose hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol povidone pregelatinized starch sodium starch glycolate stearic acid
Strengths
650 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Minor Pain Of Arthritis Muscular Aches Backache Premenstrual And Menstrual Cramps The Common Cold Headache Toothache Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: white Imprint: G650

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0357896265014
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL 1

Package Descriptions
  • PRINCIPAL DISPLAY PANEL 1

Overview

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

Indications & Usage

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

Dosage & Administration

DIRECTIONS • do not take more than directed (see overdose warning) Adults: • 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 Under 18 years of age: ask a doctor

Warnings & Precautions
WARNINGS 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 everyday 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
Purpose

PURPOSE Pain reliever/fever reducer

Do Not Use

Do not use • with any other drugs 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.

Stop Use & Ask a Doctor

Stop use and ask 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.

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

Questions

QUESTIONS OR COMMENTS ? 1-800-540-3765


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