SMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Kmart Corporation

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 160 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant

Authorization status:

OTC monograph final

Summary of Product characteristics

SMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS- ACETAMINOPHEN,
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
SUSPENSION
KMART 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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KMART CORPORATION CHILDREN’S MULTI-SYMPTOM FEVER & COLD DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 5 ML)
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
PURPOS ES
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
US ES
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if your child takes
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Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms
may include:
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temporarily relieves
minor aches and pains
headache
minor sore throat pain
runny nose
itchy nose or throat
sneezing
itchy, watery eyes due to hay fever
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a
cold
temporarily reduces fever
more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
skin reddening
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If a skin reaction occurs, stop use and seek medical help right away.
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
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ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
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ASK A DOCTOR OR PHARMACIST BEFORE USE YOUR CHILD IS TAKING
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WHEN USING THIS PRODUCT
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STOP USE AND ASK A DOCTOR IF
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blisters
rash
in a child under 4 years of age
if your child has ever had an allergic reaction to this product or any
of its ingredients
with any other drug containing acetaminophen (prescription