MAPAP EXTRA STRENGTH- acetaminophen capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Major Pharmaceuticals
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Pain reliever/ Fever reducer Temporarily reduces fever and relieves minor aches and pains due to: - headache - muscular aches - common cold - toothache - backache - minor pain of arthritis - premenstrual and menstrual cramps
Authorization status:
OTC monograph not final
Authorization number:
0904-1987-60, 0904-1987-80

MAPAP EXTRA STRENGTH- acetaminophen capsule

Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

0617 - Major

Drug Facts

Active Ingredient (in each banded capsule)

Acetaminophen 500 mg

Purpose

Purpose

Pain reliever/ Fever reducer

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

headache

muscular aches

common cold

toothache

backache

minor pain of arthritis

premenstrual and menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours

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 drugs 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 for 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 the 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.

Directions

Do not take more than directed (see overdose warning).

adults and children 12 years and over:

take 2 capsules every 6 hours while symptoms last

Do not take more than 6 capsules in 24 hours,unless directed by a doctor

Do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other information

store at room temperature

Inactive Ingredients

FD&C Blue #1, FD&C Red #40, Gelatin, Polyvinylpyrrolidone, Pregelatinized Starch, Sodium Starch

Glycolate, Stearic Acid and Titanium Dioxide

Ques tions ?

Call: (800) 616-2471

Distributed by: Major® Pharmaceuticals

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA

Re-order No. 700691 Rev.05/19 M-29 4050-05-19

Major

NDC 0904-1987-60

EXTRA STRENGTH

Mapap

Acetaminophen 500 mg Each

CAPSULES SAFETY SEALED FOR YOUR PROTECTION

SEE NEW WARNINGS INFORMATION AND DIRECTIONS

ASPIRIN FREE

Strong Pain & Fever Relief

100 CAPSULES

MAPAP EXTRA STRENGTH

acetaminophen capsule

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-19 8 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

Major Pharmaceuticals

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GELATIN (UNII: 2G8 6 QN327L)

PO VIDO NE K3 0 (UNII: U725QWY32X)

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white, red

S core

no sco re

S hap e

CAPSULE

S iz e

22mm

Flavor

Imprint Code

CPC;6 17

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 9 0 4-19 8 7-6 0

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/22/19 9 7

2

NDC:0 9 0 4-19 8 7-8 0

10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/29 /20 0 1

0 4/30 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

12/22/19 9 7

Labeler -

Major Pharmaceuticals (191427277)

Revised: 5/2020

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