Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)
Kramer Novis
ORAL
OTC DRUG
Analgesic, Antipyretic (Fever Reducer) Antihistamine Temporarily relieves minor aches and pains due to: • headache • common cold • toothache • backache • muscular aches • menstrual cramps • minor pain of arthritis. Temporarily relieves runny nose, and sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies.
OTC monograph final
DOLOGEN 325- ACETAMINOPHEN, DEXBROMPHENIRAMINE TABLET KRAMER NOVIS _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._ ---------- DOLOGEN 325 DRUG FACTS _ACTIVE INGREDIENTS (IN EACH CAPLET)_ ACETAMINOPHEN 325 MG Dexbrompheniramine Maleate 1 mg _PURPOSE_ Analgesic, Antipyretic (Fever Reducer) Antihistamine US ES : Temporarily relieves minor aches and pains due to: • headache • common cold • toothache • backache • muscular aches • menstrual cramps • minor pain of arthritis. Temporarily relieves runny nose, and sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies. WARNINGS : LIVER WARNING: This product contains ACETAMINOPHEN. Severe liver damage may occur if: • you take more than 10 tablets (3,250 mg) in 24 hours in adults or 5 tablets (1,625 mg) in 24 hours for children • Adults take more than 4,000 mg of ACETAMINOPHEN in 24 hours • your child takes more than 5 doses in 24 hours, which is the maximum daily amount • you take with other drugs containing ACETAMINOPHEN • you take 3 or more alcoholic drinks while using this product. 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. DO NOT USE : with other product containing ACETAMINOPHEN (prescription or nonprescription), this will provide more than the recommended dose (overdose) of ACETAMINOPHEN and could cause serious health concerns. If you are not sure whether a drug contains ACETAMINOPHEN, ask a doctor or pharmacist. WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSE. ASK A DOCTOR BEFORE USE IF YOU HAVE: • liver disease • breathing problems such as emphysema or chronic bronchitis • glaucoma or difficulty in urination due to enlargement of the prostate gland. DO NOT give this pr Прочитајте комплетан документ