Indications and uses
temporarily relieves minor aches and pains temporarily reduces fever
Childrens Chewable Acetaminophen
- Manufacturer
- GERI-CARE PHARMACEUTICAL CORP
- Effective date
- 2024-11-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:39:38
Label at a glance#
ProductChildrens Chewable Acetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
Chew tablets thoroughly before swallowing. This product does not contain directions or complete warnings for adults. Follow dosage on table or use as doctor directs. If possible use weight to dose; otherwise use age. Give every 4 hours as needed; do not give more than 5 doses in 24 hours. Administer only under adult supervision. DO NOT EXCEED DOSE SHOWN See Overdose Warning. Weight (lb) Under 24 24-35 36-47 48-59 ...
Storage and handling
TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store at 20°C-25°C (68°F-77°F)F); avoid high humidity Keep tightly closed Phenylketonurics: contains phenylalanine 5mg per tablet.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Acetaminophen 80 mg
Purposes
Pain Reliever/Fever Reducer
Uses
- temporarily relieves minor aches and pains
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
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.
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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if your child has
liver disease.
Ask a doctor or pharmacist before use if your child is
taking the blood thinning drug warfarin.
Stop use and ask a doctor if
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: In case of overdose, get medical
help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.
Directions
Chew tablets thoroughly before swallowing.
This product does not contain directions or complete
warnings for adults.
Follow dosage on table or use as doctor directs. If possible
use weight to dose; otherwise use age. Give every 4 hours
as needed; do not give more than 5 doses in 24 hours.
Administer only under adult supervision.
DO NOT EXCEED DOSE SHOWN
See Overdose Warning.
Weight (lb) | Under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 |
| Age | Under 2
| 2-3 | 4-5 | 6-8 | 9-10 | 11 |
| Tablets | Ask a doctor | 2 | 3 | 4 | 5 | 6 |
Other information
- TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
- store at 20°C-25°C (68°F-77°F)F); avoid high humidity
- Keep tightly closed
- Phenylketonurics: contains phenylalanine 5mg per tablet.
Inactive ingredients
Aspartame (contains phenylalanine), cellulose, D&C Red #27, Dextrose, FD&C Yellow #6, fruit flavor, magnesium stearate,
Prosweet, stearic acid, sugar
Questions or comments?
1-800-540-3765
Principal display panel
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57896-148-03 | Childrens Chewable Acetaminophen | 30 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 30 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-148-03 | EA - Each | 57896-148 | 521293ea-7221-4af4-b993-764f8327935b | 1 | 2024-12-10 |
Products#
Every source-derived product name is available through these pages.
- Childrens Chewable Acetaminophen
- Acetaminophen
- ASPARTAME
- INVERT SUGAR
- D&C RED NO. 27
- DEXTROSE
- FD&C YELLOW NO. 6
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57896-148 | 57896-148-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPARTAME | Z0H242BBR1 | IACT |
| INVERT SUGAR | ED959S6ACY | IACT |
| D&C RED NO. 27 | 2LRS185U6K | IACT |
| DEXTROSE | IY9XDZ35W2 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | GERI-CARE PHARMACEUTICAL CORP | 22f63d62-c941-5b8f-e063-6394a90aeecd | 2024-11-28 | Warnings | 57896-148-03 57896-148 57896014803 27fc23ad-7ebb-18fd-e063-6394a90ae667 22f63d62-c941-5b8f-e063-6394a90aeecd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.