foster and thrive pain reliever ACETAMINOPHEN STRATEGIC SOURCING SERVICES LLC FDA Approved Uses temporarily • reduces fever • relieves minor aches, pains, and headache
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Substance Acetaminophen
Route
RECTAL
Applications
ANDA070608
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each rectal suppository) Acetaminophen 650 mg
Inactive Ingredients
Inactive ingredient hydrogenated vegetable oil
Strengths
650 mg
Treats Conditions
Uses Temporarily Reduces Fever Relieves Minor Aches Pains And Headache

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D
Packaging

Principal Display Panel Foster & Thrive TM FOR ADULTS Pain Reliever Acetaminophen Suppositories 650 mg ACTUAL SIZE PAIN RELIEVER/FEVER REDUCER 12 RECTAL SUPPOSITORIES, 650 mg EACH Ages 12 years and older SEE NEW WARNING pain-reliever

Package Descriptions
  • Principal Display Panel Foster & Thrive TM FOR ADULTS Pain Reliever Acetaminophen Suppositories 650 mg ACTUAL SIZE PAIN RELIEVER/FEVER REDUCER 12 RECTAL SUPPOSITORIES, 650 mg EACH Ages 12 years and older SEE NEW WARNING pain-reliever

Overview

Uses temporarily • reduces fever • relieves minor aches, pains, and headache

Indications & Usage

Uses temporarily • reduces fever • relieves minor aches, pains, and headache

Dosage & Administration

Directions • do not use more than directed • remove wrapper • carefully insert suppository well up into the rectum • adults and children 12 years and older: • 1 suppository every 4 to 6 hours while symptoms last • do not exceed 6 suppositories in any 24 hour period • children under 12 years: ask a doctor

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen • an adult takes 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. For rectal use only Do not use • in children under 12 years • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if • you have liver disease • you are taking the blood thinning drug warfarin Stop use and ask a doctor if • fever lasts more than 3 days (72 hours), or recurs • pain gets worse or lasts more than 10 days • new symptoms occur • redness or swelling is present in the painful area. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.
Purpose

Purposes Pain reliever/fever reducer

Do Not Use

Do not use • in children under 12 years • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Stop Use & Ask a Doctor

Stop use and ask a doctor if • fever lasts more than 3 days (72 hours), or recurs • pain gets worse or lasts more than 10 days • new symptoms occur • redness or swelling is present in the painful area. These may be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Storage & Handling

Other information • store at 20-25 ° C (68-77 ° F) or in a cool place • tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.

Questions

Questions or comments? Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST


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