DG HEALTH FLU AND SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for s

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Dolgencorp, LLC

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 650 mg

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

DG HEALTH FLU AND SEVERE COLD AND COUGH- ACETAMINOPHEN,
DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR
SOLUTION
DOLGENCORP, 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._
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DOLGENCORP, LLC FLU & SEVERE COLD & COUGH DRUG FACTS
ACTIVE INGREDIENTS (IN EACH PACKET)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
PURPOSES
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
USES
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WARNINGS
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
you take
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temporarily relieves these symptoms due to a cold:
minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
runny nose
sneezing
itchy nose or throat
itchy, watery eyes due to hay fever
cough due to minor throat and bronchial irritation
temporarily reduces fever
more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
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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 YOU HAVE
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
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WHEN USING THIS PRODUCT
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skin reddening
blisters
rash
in a child under 12 years of age
if you have ever had an allergic reaction to this product or any of
its ingredients
with any other drug containing acetaminophen (prescription or
nonprescription). If
you are not sure whether a drug contains acetaminop