childrens mapap ACETAMINOPHEN PROFICIENT RX LP FDA Approved Uses • temporarily relieves minor aches and pains due to: o headache o sore throat o flu o toothache o the common cold • temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each chewable tablet) Acetaminophen 160 mg
Inactive Ingredients
Inactive ingredients citric acid crospovidone D&C red #27 aluminum lake D&C red #30 aluminum lake dextrates hydrated ethylcellulose flavor magnesium stearate mannitol polyethylene stearic acid sucralose
Strengths
160 mg
Quantities
700846 count
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To O Headache O Sore Throat O Flu O Toothache O The Common Cold Temporarily Reduces Fever
Pill Appearance
Shape: round Color: pink Imprint: 44;450

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0371205322243
UNII
362O9ITL9D
Packaging

Principal Display Panel MAJOR ® NDC 71205-322-24 Children's Māpap® ACETAMINOPHEN 160 mg Chewable Tablets Pain reliever / Fever reducer ASPIRIN FREE • IBUPROFEN FREE AGES 2-11 Chew or crush tablets completely before swallowing. 24 Chewable Tablets, 160 mg EACH Bubble Gum Flavor TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Distributed by MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA M-17 Relabeled by PROFICIENT RX LP Thousand Oaks, CA 91320 Rev. 11/18 Re-order No. 700846 50844 REV1018B45008 71205-322-24

Package Descriptions
  • Principal Display Panel MAJOR ® NDC 71205-322-24 Children's Māpap® ACETAMINOPHEN 160 mg Chewable Tablets Pain reliever / Fever reducer ASPIRIN FREE • IBUPROFEN FREE AGES 2-11 Chew or crush tablets completely before swallowing. 24 Chewable Tablets, 160 mg EACH Bubble Gum Flavor TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Distributed by MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA M-17 Relabeled by PROFICIENT RX LP Thousand Oaks, CA 91320 Rev. 11/18 Re-order No. 700846 50844 REV1018B45008 71205-322-24

Overview

Uses • temporarily relieves minor aches and pains due to: o headache o sore throat o flu o toothache o the common cold • temporarily reduces fever

Indications & Usage

Uses • temporarily relieves minor aches and pains due to: o headache o sore throat o flu o toothache o the common cold • temporarily reduces fever

Dosage & Administration

Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed • find the right dose on chart below. If possible, use weight to dose; otherwise, use age. • chew or crush tablets completely before swallowing; do not swallow tablets whole • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (chewable tablets)* Under 24 Under 2 Ask a doctor 24-35 2-3 1 tablet 36-47 4-5 1 1/2 tablets 48-59 6-8 2 tablets 60-71 9-10 2 1/2 tablets 72-95 11 3 tablets *or as directed by a doctor

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if • pain gets worse or lasts more than 5 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. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

When Using

When using this product do not exceed recommended dosage.

Stop Use & Ask a Doctor

Stop use and ask a doctor if • pain gets worse or lasts more than 5 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. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • avoid high humidity • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) • see end flap for expiration date and lot number

Questions

Questions or comments? (800) 616-2471


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