The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient: Acetaminophen 160 mg (in each 5 mL (TSP))
Otc - Purpose
Purpose: Pain reliever/fever reducer
Indications & Usage
- Uses To reduce fever and for the temporary relief of minor aches and pains due to: •Headache •Muscular aches •Backache •Minor pain of arthritis •The common cold •Toothache •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.
Otc - Do Not Use
- 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
Otc - When Using
- When using this product •do not exceed recommended dose (see overdose warning)
Otc - Stop Use
- 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 conditionIf pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) 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 (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)Other information 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.
888-974-5279 This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®. Manufactured by:Silarx Pharmaceuticals, Inc1033 Stoneleigh Ave.Carmel, NY 10512USARelabeled by:Proficient Rx LPThousand Oaks, CA 91320
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