FDA Label for Acetaminophen
View Indications, Usage & Precautions
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Uses
for the temporary relief of minor aches and pains associated with
- a cold or flu
- sore throat
- headache
- toothache
- temporarily reduces fever
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.
Otc - Do Not Use
Do not use
- with any other product containing acetaminophen
- more than directed (see overdose warning)
Otc - Ask Doctor
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts for more than 5 days
- fever gets worse or lasts more than 3 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. 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 children even if you do not notice any signs or symptoms.
Directions
- find right dose on chart
- if possible, use weight to dose; otherwise, use age
- if needed, repeat dose every 4 hours
- do not use more than 5 times in 24 hours
| Weight | Age | Dose |
|---|---|---|
| under 24 lbs | under 2 years | ask a doctor |
| 24 to 35 lbs | 2 to 3 years | 1 teaspoon (5 mL) |
| 36 to 47 lbs | 4 to 5 years | 1 ½ teaspoons (7.5 mL) |
| 48 to 59 lbs | 6 to 8 years | 2 teaspoons (10 mL) |
| 60 to 71 lbs | 9 to 10 years | 2 ½ teaspoons (12.5 mL) |
| 72 to 95 lbs | 11 years | 3 teaspoons (15 mL) |
Other Information
store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
artificial cherry flavor, benzoic acid, citric acid, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose
Questions?
Call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time
Principal Display Panel
ACETAMINOPHEN
ORAL SOLUTION USP
160 mg/5 mL
PAIN RELIEVER - FEVER REDUCER
Alcohol-Free
Aspirin-Free
Saccharin-Free
Cherry-Flavored
EACH TEASPOON (5 mL) CONTAINS:
Acetaminophen USP 160 mg
TAMPER-EVIDENT: Do not use this product if
inner foil seal over the mouth of the bottle
is cut, torn, broken or missing.
THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN
Distributed by:
GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960
Dist. 1990 0809REV 71
Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146
NDC 54868-1791-0
TAMPER-EVIDENT
ONE PINT (473 mL)
* Please review the disclaimer below.