8 hr Pain Relief ACETAMINOPHEN DOLGENCORP, INC. FDA Approved Uses • temporarily relieves minor aches and pains due to: o muscular aches o backache o minor pain of arthritis o toothache o premenstrual and menstrual cramps o headache o the common cold • temporarily reduces fever
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
ANDA215486
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Acetaminophen 650 mg
Inactive Ingredients
Inactive ingredients carnauba wax hydroxyethyl cellulose hypromellose magnesium stearate microcrystalline cellulose povidone pregelatinized starch sodium starch glycolate titanium dioxide triacetin
Strengths
650 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To O Muscular Aches O Backache O Minor Pain Of Arthritis O Toothache O Premenstrual And Menstrual Cramps O Headache O The Common Cold Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: white Imprint: 71

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0355910895056
UNII
362O9ITL9D
Packaging

704R-DG-APAP-50s-Label 704R-DG-APAP-50s-ifc

Package Descriptions
  • 704R-DG-APAP-50s-Label 704R-DG-APAP-50s-ifc

Overview

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

Indications & Usage

Uses • temporarily relieves minor aches and pains due to: o muscular aches o backache o minor pain of arthritis o toothache o premenstrual and menstrual cramps o headache o 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. 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. 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 20-25ºC (68-77ºF) • The FDA approved Dissolution methods differ from USP

Questions

Questions or comments? Call 1-877-290-4008


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