M-PAP- acetaminophen liquid 
Method Pharmaceuticals, LLC

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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M-PAP

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:

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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. 

8 teaspoonfuls (40 mL) in 24 hours 

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

PRINCIPAL DISPLAY PANEL

NDC 58657-525-04
M-PAP
Acetaminophen Liquid
160 mg/5 mL
Cherry Flavor
4 fl. oz. (120 mL)

PRINCIPAL DISPLAY PANEL
NDC 58657-525-04
M-PAP
Acetaminophen Liquid
160 mg/5 mL
Cherry Flavor
4 fl. oz. (120 mL)

PRINCIPAL DISPLAY PANEL

NDC 58657-525-16
M-PAP
Acetaminophen Liquid
160 mg/5 mL
Cherry Flavor
16 fl. oz. (473 mL)

PRINCIPAL DISPLAY PANEL
NDC 58657-525-16
M-PAP
Acetaminophen Liquid
160 mg/5 mL
Cherry Flavor
16 fl. oz. (473 mL)

M-PAP 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-525
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58657-525-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2019
2NDC:58657-525-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/01/2019
Labeler - Method Pharmaceuticals, LLC (060216698)

Revised: 8/2019
Document Id: 5c38191e-8368-4065-ad46-0499748149fe
Set id: 3d1bb61c-15db-4eba-aba9-cfbcbc7b30e0
Version: 1
Effective Time: 20190801
 
Method Pharmaceuticals, LLC