Acetaminophen by H.J. Harkins Company, Inc.
Dosage form: liquid
Ingredients: Acetaminophen 160mg in 5mL
Labeler: H.J. Harkins Company, Inc.
NDC Code: 52959-309
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.
Active Ingredient: Acetaminophen 160 mg (in each 5 mL = 1 teaspoonful)
Purpose: Pain reliever/fever reducer
Uses temporarily relieves minor aches and pains due to: the common cold
- sore throat
- temporarily reduces fever
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
more than 5 of the recommended doses per day
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
Alcohol warning:If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.
Do not use
- with any other product containing acetaminophen.
When using this product
- do not exceed recommended dose (see overdose warning)
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 for more than 3 days
Keep out of 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 even if you do not notice any signs of symptoms.
- do not take more than directed (see overdose warning).
- if needed, repeat dose every 4 hours or as directed by a doctor
- do not give more than 5 doses in 24 hours
|children under 2 yrs (under 24 lbs)||ask a doctor
|children 2-3 years (24-35 lbs)||1 teaspoonful (5 mL)
|children 4-5 years (36-47 lbs)||1 1/2 teaspoonfuls (7.5 mL)
|children 6-8 years (48-59 lbs)||2 teaspoonfuls (10 mL)
|children 9-10 years (60-71 lbs)||2 1/2 teaspoonfuls (12.5 mL)
|children 11 years (72-95 lbs)||3 teaspoonfuls (15 mL)
|adults & children 12 years & older||4 teaspoonfuls (20 mL)
Store at room temperature 20°-25°C (68°-77°F)
citric acid, D&C red no. 33, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, and purified water.
This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®.
Silarx Pharmaceuticals, Inc
19 West Street
Spring Valley, NY 10977
H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444
|Labeler - H.J. Harkins Company, Inc. (147681894)|
|Silarx Pharmaceuticals, Inc||161630033||manufacture|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.