OTC Medication Information: M-PAP

M-PAP- acetaminophen liquid
Bryant Ranch Prepack

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.

M-PAP

Acetaminophen Liquid

160 mg/5 mL

Pain Reliever / Fever Reducer

Sugar Free / Alcohol Free

Aspirin Free

CHERRY FLAVOR

Drug Facts

Active ingredient

(in each 5 mL teaspoonful)

Acetaminophen, USP 160 mg ………………..

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

  • Headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • reduces fever

Warnings

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

  • more than 8 teaspoonfuls (40 mL) 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.

Ask a doctor before use

if you have health issues especially liver disease.

Ask a doctor or pharmacist before use

if you are taking other drugs, including the blood thinner warfarin.

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.

  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Stop use and ask a doctor if

  • new symptoms occur such as rash, hives, itching or hoarseness

  • redness or swelling is present

  • pain gets worse or lasts for more than 10 days

  • fever gets worse or lasts for more than 3 days

  • symptoms do not improve

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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

Do not exceed recommended dosage.

Overdose Warnings: Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.

  • adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed

8 teaspoonfuls (40 mL) in 24 hours

  • children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.

Other Information

If dispensed, dispense in a tight, light resistant container with a child-resistant cap.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Inactive Ingredients

Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.

Questions?

1-877-250-3427 M-F (8 a.m. to 5 p.m. CST), or directly to Medwatch at 1-800-332-1088.

Serious side effects associated with use of this product may be reported to this number.

See New Warnings Information

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

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.

Distributed by:

Method Pharmaceuticals

Fort Worth, Texas 76118

Rev. 06/19

HOW SUPPLIED

NDC: 63629-1157-1 120 mL in a BOTTLE

M-PAP Oral Liquid 160 MG/5ML

Label
(click image for full-size original)
M-PAP acetaminophen liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63629-1157(NDC:58657-525)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SACCHARIN SODIUM
SORBITOL
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-1157-1 120 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 08/01/2019
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-1157), RELABEL (63629-1157)

Revised: 04/2022 Bryant Ranch Prepack

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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