Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Salado Sales, Inc.
ORAL
OTC DRUG
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: - headache - sore throat - flu - toothache - the common cold - temporarily reduces fever
OTC monograph not final
CHILDRENS CHEWABLE- ACETAMINOPHEN TABLET, CHEWABLE SALADO SALES, INC. _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._ ---------- CVP 44-450 _ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)_ Acetaminophen 160 mg _PURPOSE_ Pain reliever/fever reducer _USES_ temporarily relieves minor aches and pains due to: headache sore throat flu toothache the common cold 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. 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. 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. WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSAGE. 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. In case of accidental overdose, get medical help or contact a Poison Control Center (1- 800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do Read the complete document