Diphenhydramine HCI, Phenylephrine HCl

FDA Drug Profile — Cold and Congestion Childrens Nighttime

Diphenhydramine HCI, Phenylephrine HCl is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Cold and Congestion Childrens Nighttime. Available dosage form: liquid.

Drug Details

Generic Name
Diphenhydramine HCI, Phenylephrine HCl
Brand Names
Cold and Congestion Childrens Nighttime
Application Number
M012
Sponsor
Walgreens
NDC Codes
1
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these symptoms occuring with a cold, hay fever, or other upper respiratory allergies nasal congestion cough runny nose sneezing itchy, watery eyes itching of the nose or throat

Warnings

Warnings Do not use to sedate a child or to make a child sleepy 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. with any other product containing diphenhydramine, even one used on skin. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlem (mucus) a breathing problem or chronic cough that last or as occurs with smoking, asthma, chronic bronchitis, or emphysena. Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with a fever cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. 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 (1-800-222-1222) right away.