[Silarx Pharmaceuticals, Inc]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph not final|
Uses To reduce fever and for the temporary relief of minor aches and pains due to:
- Muscular aches
- Minor pain of arthritis
- The common cold
- Premenstrual and menstrual cramps
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
more than 5 doses 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
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 the user consumes 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if the user is allergic to acetaminophen or any of the inactive ingredients in this product
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
- These could be signs of a serious condition
If pregnant or breast-feeding, ask a health professional before use.
- 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 (TSP)(5 mL)
|children 4-5 years (36-47 lbs)||1 1/2 teaspoonfuls (TSP)(7.5 mL)
|children 6-8 years (48-59 lbs)||2 teaspoonfuls (TSP)(10 mL)
|children 9-10 years (60-71 lbs)||2 1/2 teaspoonfuls (TSP)(12.5 mL)
|children 11 years (72-95 lbs)||3 teaspoonfuls (TSP)(15 mL)
|adults & children 12 years & older||4 teaspoonfuls (TSP)(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
1033 Stoneleigh Ave.
Carmel, NY 10512
|Labeler - Silarx Pharmaceuticals, Inc (078500185)|