DAYTIME COLD AND COUGH AND NIGHTTIME COLD AND CONGESTION CHILDRENS- brompheniramine maleate, dextromethorphan hbr, phenylephrine

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

TARGET Corporation

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 10 mL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine / Cough suppressant Nasal Decongestant Antihistamine Cough suppressant Nasal decongestant Nighttime - 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 Daytime - temporaily relieves cough due to minor throat and bronchial irritation occuring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies - temporarily relieves these symptoms due to hay fever (allergic rhinitis) runny nose itchy, watery eyes sneezing itching of the nose or throat - runny nose - itchy, watery eyes - sneezing - itching of the nose or throat - temporarily restores freer breathing through the nose

Authorization status:

OTC monograph final

Summary of Product characteristics

DAYTIME COLD AND COUGH AND NIGHTTIME COLD AND
CONGESTION CHILDRENS- BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR,
PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
TARGET CORPORATION
_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._
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DRUG FACTS
ACTIVE INGREDIENTS FOR NIGHTTIME (IN EACH 10 ML)
Diphenhydramine HCI 12.5 mg
Phenylephrine HCI 5 mg
ACTIVE INGREDIENTS FOR DAYTIME (IN EACH 10 ML)
Brompheniramine Maleate 2 mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5 mg
PURPOSE FOR NIGHTTIME
Antihistamine / Cough suppressant
Nasal Decongestant
PURPOSE FOR DAYTIME
Antihistamine
Cough suppressant
Nasal decongestant
USES
NIGHTTIME
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
DAYTIME
temporaily relieves cough due to minor throat and bronchial irritation
occuring with a
cold, and nasal congestion due to the common cold, hay fever or other
upper
respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic
rhinitis)
runny nose
itchy, watery eyes
sneezing
itching of the nose or throat
temporarily restores freer breathing through the nose
WARNINGS
DO NOT USE
NIGHTTIME
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.
DAYTIME
to sedate a child or to make sleepy
if you are now taking a prescription monoamine oxidase inhibitor
(MAOI)(certain
drugs for depression,psychiatic or emotional cond