Label: M-PAP- acetaminophen liquid
- NDC Code(s): 63629-1157-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 58657-525
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 20, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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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 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.
- more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount
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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
- Inactive Ingredients
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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
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
M-PAP
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63629-1157(NDC:58657-525) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-1157-1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/01/2019 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-1157) , RELABEL(63629-1157)
