8 Hour Pain Relief ACETAMINOPHEN CHAIN DRUG MARKETING ASSOCIATION, INC. FDA Approved 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
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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 Muscular Aches Backache Minor Pain Of Arthritis Toothache Premenstrual And Menstrual Cramps Headache The Common Cold Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: white Imprint: G650

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL QUALITY CHOICE® NDC 83324-082-50 †Compare to Active Ingredient in Tylenol® 8HR Muscle Aches and Pain 8 Hour Pain Relief Acetaminophen Extended Release Tablets, 650 mg Pain Reliever | Fever Reducer For up to 8 Hour Relief of Minor Muscle Aches and Pain Actual Size 50 CAPLETS** - 650 MG EACH (**Capsule-Shaped Bi-Layer Tablets) image description

Package Descriptions
  • PRINCIPAL DISPLAY PANEL QUALITY CHOICE® NDC 83324-082-50 †Compare to Active Ingredient in Tylenol® 8HR Muscle Aches and Pain 8 Hour Pain Relief Acetaminophen Extended Release Tablets, 650 mg Pain Reliever | Fever Reducer For up to 8 Hour Relief of Minor Muscle Aches and Pain Actual Size 50 CAPLETS** - 650 MG EACH (**Capsule-Shaped Bi-Layer Tablets) image description

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over 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, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years do not use

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 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. 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.
Purpose

Purpose Pain reliever/fever reducer

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

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other information store between 20-25°C (68-77°F) retain carton for complete product information and warnings


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