Indications and uses
temporarily relieves minor aches and pains due to: Headache muscular aches backache arthritis the common cold toothache menstrual cramps reduces fever
M-PAP
- Manufacturer
- Method Pharmaceuticals, LLC
- Effective date
- 2025-10-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 01:41:14
Label at a glance#
ProductM-PAP
Active ingredientACETAMINOPHEN
Label structure11 sections
Dosage and administration
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.
Storage and handling
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)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
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
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)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 6 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 6 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 6 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 6 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 6 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 6 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 6 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58657-525-04 | M-PAP | 120 mL in 1 BOTTLE | LIQUID | 120 | 6 | |
| 58657-525-16 | M-PAP | 473 mL in 1 BOTTLE | LIQUID | 473 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58657-525-04 | ML - Milliliter | 58657-525 | 64573b7b-b406-4e75-a90e-4f58d9aa56d4 | 1 | 2019-09-05 |
| 58657-525-16 | ML - Milliliter | 58657-525 | 6b398395-119f-4ccf-9f37-9fffa24d4341 | 1 | 2019-09-05 |
Products#
Every source-derived product name is available through these pages.
- M-PAP
- Acetaminophen
- CITRIC ACID MONOHYDRATE
- FD&C RED NO. 40
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
- SACCHARIN SODIUM
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58657-525 | 58657-525-04, 58657-525-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2024-11-24 | full-release | 2026-06-01 00:38:58 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| M-PAP | ACETAMINOPHEN | Method Pharmaceuticals, LLC | 3d1bb61c-15db-4eba-aba9-cfbcbc7b30e0 | 2025-10-21 | Warnings | 58657-525-04 58657-525-16 58657-525 58657052504 58657052516 41b5d614-1445-e68c-e063-6394a90ae714 3d1bb61c-15db-4eba-aba9-cfbcbc7b30e0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.