COLD AND SORE THROAT- acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Cellchem Pharmaceuticals Inc

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Relives: 

Authorization status:

OTC monograph final

Summary of Product characteristics

COLD AND SORE THROAT- ACETAMINOPHEN, PHENIRAMINE MALEATE,
PHENYLEPHRINE HYDROCHLORIDE POWDER
CELLCHEM PHARMACEUTICALS 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._
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COLD & SORE THROAT
DRUG FACTS
ACTIVE INGREDIENTS (in each packet) PURPOSE
ACETAMINOPHEN 325
mg...................................................Pain
reliever/Fever reducer
Pheniramine maleate 20
mg................................................Antihistamine
Phenylephrine Hydrochloride 10
mg......................................Nasal decongestant
USES
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Relives:
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WARNINGS
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur
Temporarily relieves these symptoms due to cold:
o
o
o
o
minor aches and pains
minor sore throat pain
headache
nasal congestion
Temporarily reduces fever
Temporarily relieves these symptoms due to hay fever or other upper
respiratory
allergies:
o
o
o
o
runny nose
sneezing
itchy nose and throat
itchy, watery eyes
Nasal congestion
Body aches
Headache
Runny nose
Sore throat pain
Fever
if you take:
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ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may include
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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 YOU HAVE
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
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IF PREGNANT OR BREAST-FEEDING, ask a health care professional before
use.
WHEN USING THIS PRODUCT
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more than 6 packets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product.
skin reddening
blisters
rash. If a skin reaction occurs, stop use and seek medical help right
aw