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

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 Minor Pain Of Arthritis O Muscular Aches O Backache O Premenstrual And Menstrual Cramps O The Common Cold O Headache O Toothache Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: white Imprint: 71

Identifiers & Packaging

Container Type UNKNOWN
UPC
0355910892420 0355910892260 0355910892055
UNII
362O9ITL9D
Packaging

699R-DG-APAP-225s-Label 699R-DG-APAP-225s-ifc 699R-DG-APAP-50s-Label 699R-DG-APAP-50s-ifc 699R-DG-APAP-24s-Label 699R-DG-APAP-24s-ifc

Package Descriptions
  • 699R-DG-APAP-225s-Label 699R-DG-APAP-225s-ifc 699R-DG-APAP-50s-Label 699R-DG-APAP-50s-ifc 699R-DG-APAP-24s-Label 699R-DG-APAP-24s-ifc

Overview

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

Indications & Usage

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

Questions

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


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →