MAPAP- mapap tablet

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
DirectRX
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purposes Pain reliever/fever reducer Uses for the temporary relief of minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
61919-875-71

MAPAP- mapap tablet

DirectRX

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.

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MAPAP

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Uses

for the temporary relief of minor aches and pains due to:

headache

muscular aches

backache

minor pain of arthritis

the common cold

toothache

premenstrual and menstrual cramps

temporarily reduces fever

Warnings

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

adult takes more than 4,000 mg in 24 hours

child takes more than 5 doses in 24 hours, which is the maximum daily amount

taken with other drugs containing acetaminophen

adult has 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 the user has liver disease.

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days in adults

pain gets worse or lasts more than 5 days in children under 12 years

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.

Directions

do not take more than directed (see overdose warning)

AGE DOSE

Adults and children 12 years and over

take 2 tablets every 4 to 6 hours while symptoms last

do not take more than 10 tablets in 24 hours, unless directed by a doctor

do not use for more than 10 days unless directed by a doctor

Children 6 years to under 12 years

take 1 tablet every 4 to 6 hours while symptoms last

do not take more than 5 tablets in 24 hours

do not use for more than 5 days unless directed by a doctor

Children under 6 years ask a doctor

Other information

Store at room temperature

Inactive ingredients

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?Call (800) 616-2471

Do not use if imprinted Safety Seal under cap is broken or missing

Distributed By: MAJOR® PHARMACEUTICALS

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

Keep out of reach of children.

MAPAP

mapap tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 19 19 -8 75(NDC:0 9 0 4-19 8 2)

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

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PO VIDO NE K12 (UNII: 333AG72FWJ)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND (flat faced beveled edge)

S iz e

10 mm

Flavor

Imprint Code

GPI;A325

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -8 75-71

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

0 5/0 1/20 19

Dire ctRX

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

0 5/0 1/20 19

Labeler -

DirectRX (079254320)

Registrant -

DirectRX (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c tRX

0 79 254320

re pa c k(6 19 19 -8 75)

Revised: 5/2019

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