DG HEALTH COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

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), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)

Available from:

Dolgencorp Inc

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Cough suppressant Antihistamine temporarily relieves common cold/flu symptoms:

Authorization status:

OTC monograph final

Summary of Product characteristics

DG HEALTH COLD AND FLU RELIEF- ACETAMINOPHEN, DEXTROMETHORPHAN HBR,
DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED
DOLGENCORP 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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DOLGENCORP, LLC COLD & FLU RELIEF DRUG FACTS
ACTIVE INGREDIENTS (IN EACH SOFTGEL)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
PURPOSE
Pain reliever/fever reducer
Cough suppressant
Antihistamine
USES
temporarily relieves common cold/flu symptoms:
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WARNINGS
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
you take
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ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
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cough due to minor throat and bronchial irritation
minor aches and pains
runny nose and sneezing
sore throat
headache
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
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, lasts 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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STOP USE AND ASK A DOCTOR IF
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blisters
rash
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 now taking a prescription monoamine oxidase inhibitor
(MAOI) (certain
drugs for depression, psychiatric, or emotional conditions, or
Parkinson’s disease),
or for 2 weeks after stopping the MAOI drug. If you do not know if