Country: United States
Language: English
Source: NLM (National Library of Medicine)
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)
Publix Super Markets Inc
ORAL
OTC DRUG
Antihistamine Nasal decongestant
OTC monograph final
CHILDRENS COLD AND ALLERGY- PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE SOLUTION PUBLIX SUPER MARKETS 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._ ---------- PUBLIX SUPER MARKETS, INC. CHILDREN’S COLD & ALLERGY DRUG FACTS ACTIVE INGREDIENTS (IN EACH 10 ML) Brompheniramine maleate, USP 2 mg Phenylephrine HCl, USP 5 mg PURPOS ES Antihistamine Nasal decongestant US ES • • • • • • • WARNINGS DO NOT USE • • ASK A DOCTOR BEFORE USE IF YOU HAVE • • • • • • • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): sneezing itching of the nose or throat runny nose itchy, watery eyes temporarily restores freer breathing through the nose if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleepy heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers WHEN USING THIS PRODUCT • • • • • • STOP USE AND ASK A DOCTOR IF • • IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). DIRECTIONS • • • • age dose adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use OTHER Read the complete document