ONLY FOR COLD AND FLU COUGH SUPPRESSANT- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

O4 Global Trading Usa, Llc

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/Fever reducer Cough suppressant Expectorant Nasal decongestant • temporarily relieves:      • minor aches & pains associated with a cold, the flu or a sore throat • headache • cough due to minor throat & bronchial irritation • nasal congestion • sinus congestion & pressure • temporarily reduces fever • reduces swelling in nasal passages • promotes nasal and/or sinus drainage • temporarily restores free breathing through the nose • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, and make coughs more productive

Authorization status:

OTC monograph final

Summary of Product characteristics

ONLY FOR COLD AND FLU COUGH SUPPRESSANT- ACETAMINOPHEN,
DEXTROMETHORPHAN
HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET
O4 GLOBAL TRADING USA, LLC
_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._
----------
_ONLY FOR_- COLD & FLU COUGH SUPPRESSANT
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH CAPLET)_
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
_PURPOSE_
Pain reliever/Fever reducer
Cough suppressant
Expectorant
Nasal decongestant
_USES:_
• temporarily relieves:
• minor aches & pains associated with a cold, the flu or a sore
throat • headache • cough due to
minor throat & bronchial irritation • nasal congestion • sinus
congestion & pressure
• temporarily reduces fever • reduces swelling in nasal passages
• promotes nasal and/or sinus drainage • temporarily restores free
breathing through the nose
• Helps loosen phlegm (mucus) and thin bronchial secretions to rid
the bronchial passageways of
bothersome mucus, and make coughs more productive
_WARNINGS:_
LIVER WARNING:
This product contains acetaminophen.
Severe liver damage may occur if you take: • with other drugs
containing acetaminophen
• more than 8 caplets in 24 hrs, which is the maximum daily amount
for this product
• 3 or more alcoholic drinks every day while using this product
ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may include:
• Skin reddening • blisters • rash
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
• with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are no