Indications and uses
temporarily relieves minor aches and pains due to: headache toothache sore throat the common cold flu temporarily reduces fever
temporarily relieves minor aches and pains due to: headache toothache sore throat the common cold flu temporarily reduces fever
this product does not contain directions or complete warnings for adult use do not give more than directed find the right dose on chart below. If possible, use weight to dose; otherwise, use age. chew or crush tablets completely before swallowing; do not swallow tablets whole repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (chewable tablets)* Under ...
avoid high humidity store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Acetaminophen 80 mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
liver disease.
taking the blood thinning drug warfarin.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Weight (lb) | Age (yr) | Dose (chewable tablets)* |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 2 tablets |
| 36-47 | 4-5 | 3 tablets |
| 48-59 | 6-8 | 4 tablets |
| 60-71 | 9-10 | 5 tablets |
| 72-95 | 11 | 6 tablets |
*or as directed by a doctor
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose
1-800-426-9391
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0309045791462 | GTIN-13: 0309045791462 EAN-13: 0309045791462 GTIN-12: 309045791462 UPC-A: 309045791462 GTIN storage (14 digits): 00309045791462 | major-44-452-1.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5791-46 | EA - Each | 0904-5791 | ccb7c15f-a886-4b5c-abd3-3a13255dcfd2 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 5 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 5 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 5 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 5 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | 5 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 5 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 5 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 5 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0904-5791 | 0904-5791-46 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 22 | 2026-02-04 | full-release | 2026-06-01 01:46:26 |
| 21 | 2026-01-12 | monthly-update | 2026-06-03 17:52:41 |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 52.5 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, DELAYED RELEASE / ORAL | 53.8 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | POWDER / ORAL | 2090 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, EXTENDED RELEASE / ORAL | 1120 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | CAPSULE, EXTENDED RELEASE / ORAL | 153 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, DELAYED RELEASE / ORAL | 53.8 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, EXTENDED RELEASE / ORAL | 1120 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, CHEWABLE / ORAL | 3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | CAPSULE / ORAL | 12.32 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, COATED / ORAL | 20 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET / ORAL | 300 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, COATED / ORAL | 20 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, CHEWABLE / ORAL | 3 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, CHEWABLE / ORAL | 3726 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | POWDER / ORAL | 2090 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | CAPSULE, EXTENDED RELEASE / ORAL | 153 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | POWDER, FOR SUSPENSION / ORAL | NA | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | CAPSULE / ORAL | 12.32 mg |
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 |
|---|---|---|---|---|---|---|
| Childrens Mapap | ACETAMINOPHEN | Major Pharmaceuticals | efec6af2-8b26-47f6-88c8-b0a6d69a2d7d | 2026-06-03 | Warnings | 0904-5791-46 0904-5791 00904579146 2bd5ccbd-a062-4af1-bc34-99498594c2ba efec6af2-8b26-47f6-88c8-b0a6d69a2d7d |
Adverse event summaries are temporarily unavailable. Other product information remains available.