TEXACLEAR NIGHT TIME COUGH COLD/FLU- choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

GM Pharmaceuticals, INC

INN (International Name):

CHOLINE SALICYLATE

Composition:

CHOLINE SALICYLATE 870 mg in 30 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever / fever reducer Antihistamine   Nasal decongestant - temporarily relieves these common cold and flu symptoms: - nasal congestion - minor aches and pains - runny nose - sneezing - watery eyes - sore throat - headache - temporarily reduces fever

Authorization status:

OTC monograph final

Summary of Product characteristics

TEXACLEAR NIGHT TIME COUGH COLD/FLU- CHOLINE SALICYLATE,
DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID
GM PHARMACEUTICALS, INC
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TEXACLEAR NIGHT TIME COUGH COLD FLU
TEXACLEAR NIGHT TIME COUGH COLD/FLU- (choline salicylate,
diphenhydramine
hydrochloride, phenylephrine hydrochloride) liquid
GM Pharmaceuticals, Inc.
----------
TEXACLEAR NIGHT TIME COUGH COLD/FLU
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 30 ML)
Choline Salicylate (NSAID)* 870 mg
Diphenhydramine HCl 50 mg
Phenylephrine HCl 10 mg
*nonsteroidal anti-inflammatory drug
PURPOSE
Pain reliever / fever reducer
Antihistamine
Nasal decongestant
USES
temporarily relieves these common cold and flu symptoms:
nasal congestion
minor aches and pains
runny nose
sneezing
watery eyes
sore throat
headache
temporarily reduces fever
WARNINGS
REYE'S SYNDROME
Children and teenagers who have or are recovering from chicken pox or
flu-like
symptoms should not use this product. When using this product, if
changes in behavior
with nausea and vomiting occur, consult a doctor because these
symptoms could be an
early sign of Reye's syndrome, a rare but serious illness.
ALLERGY ALERT
Salicylates (NSAIDs) may cause a severe allergic reaction which may
include:
hives
rash
shock
skin reddening
facial swelling
asthma (wheezing)
STOMACH BLEEDING WARNINGS
This product contains an NSAID, which may cause severe stomach
bleeding. The chance
is higher if you:
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or non-prescription NSAIDs
(aspirin,
ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
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
■ in children under 12 years of age
■ if you have ever had an allergic reaction to sal