DIMETAPP MULTI-SYMPTOM COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution

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:

Foundation Consumer Brands

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves these common cold and flu symptoms: minor aches and pains headache nasal congestion sore throat cough runny nose itching of the nose or throat sneezing - minor aches and pains - headache - nasal congestion - sore throat - cough - runny nose - itching of the nose or throat - sneezing - temporarily reduces fever - temporarily restores freer breathing through the nose

Authorization status:

unapproved drug other

Summary of Product characteristics

DIMETAPP MULTI-SYMPTOM COLD AND FLU- ACETAMINOPHEN,
DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE
SOLUTION
FOUNDATION CONSUMER BRANDS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
DIMETAPP
MULTI-SYMPTOM COLD AND FLU
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN_
_EACH 10 ML)_
_PURPOSES_
Acetaminophen, 320 mg
Pain reliever/fever reducer
Diphenhydramine HCl,
12.5 mg
Antihistamine/cough
suppressant
Phenylephrine HCl, 5 mg
Nasal decongestant
USES
temporarily relieves these common cold and flu symptoms:
minor aches and pains
headache
nasal congestion
sore throat
cough
runny nose
itching of the nose or throat
sneezing
temporarily reduces fever
temporarily restores freer breathing through the nose
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
adult takes more than 6 doses in 24 hours, which is the maximum daily
amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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
to sedate a child or to make a child sleepy
in a child under 6 years of age
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
your prescription
drug contains an MAOI, ask a doctor or pharmacist before taking this
product.
with any other drug containing acetaminophen (prescription or
nonprescript