basic care acetaminophen ACETAMINOPHEN AMAZON.COM SERVICES LLC 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
ANDA075077
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Acetaminophen 650 mg
Inactive Ingredients
Inactive ingredients carnauba wax colloidal silicon dioxide croscarmellose sodium hypromellose magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol polysorbate 80 povidone pregelatinized starch stearic acid titanium dioxide
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: oval Color: white Imprint: L544

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D
Packaging

Package/Label Principal Display Panel amazon basic care 8 Hour Pain Relief Compare to Tylenol® 8HR Caplets active ingredient Acetaminophen Extended-Release Tablets, 650 mg Pain Reliever/Fever Reducer For up to 8 Hours of Minor Muscle Aches and Pain actual size 100 CAPLETS* - 650 mg EACH *CAPSULE-SHAPED TABLETS 5S1-bn-acetaminophen

Package Descriptions
  • Package/Label Principal Display Panel amazon basic care 8 Hour Pain Relief Compare to Tylenol® 8HR Caplets active ingredient Acetaminophen Extended-Release Tablets, 650 mg Pain Reliever/Fever Reducer For up to 8 Hours of Minor Muscle Aches and Pain actual size 100 CAPLETS* - 650 mg EACH *CAPSULE-SHAPED TABLETS 5S1-bn-acetaminophen

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 • 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
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. 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.

Storage & Handling

Other information • store at 20-25 ° C (68-77 ° F) • do not use if printed foil under cap is broken or missing • meets the requirements of USP Dissolution Test 2

Questions

Questions or comments? 1-800-719-9260


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