CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
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.
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Active ingredients (in each 10 ml)
Acetaminophen, USP 320 mg
Diphenhydramine HCl, USP 12.5 mg
Phenylephrine HCl, USP 5 mg
Purposes
Pain reliever/Fever reducer
Antihistamine/Cough suppressant
Nasal decongestant
Uses
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- temporarily relieves these symptoms associated with a cold, or flu:
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- headache
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- sore throat
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- fever
- •
- minor aches and pains
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- temporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a cold
- •
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- •
- sneezing
- •
- itching of the nose or throat
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- itchy, watery eyes
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- runny nose
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- temporarily restores freer breathing through the nose
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if user takes
- •
- more than 5 doses in any 24-hour period, which is the maximum daily amount
- •
- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using this product
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
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- in a child under 6 years of age
- •
- if user is 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 nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
- •
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if user has
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if user is
- •
- taking the blood thinning drug warfarin
- •
- taking any other oral nasal decongestant or stimulant
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- taking any other pain reliever/fever reducer
- •
- taking sedatives or tranquilizers
When using this product
- •
-
do not use more than directed
- •
- marked drowsiness may occur
- •
- avoid alcoholic drinks
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
- •
- excitability may occur, especially in children
Stop use and ask a doctor if
- •
- user gets nervous, dizzy, or sleepless
- •
- pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
- •
- fever gets worse or lasts more than 3 days
- •
- redness or swelling is present
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- •
- new symptoms occur
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
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- do not take more than 5 doses in any 24-hour period
- •
- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
- •
- measure only with dosage cup provided
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- keep dosage cup with product
- •
- ml = milliliter
age | dose |
adults and children 12 years and over
|
20 ml every 4 hours
|
children 6 to 12 years
|
10 ml every 4 hours
|
children under 6 years
|
do not use
|
Other information
- •
-
each 10 ml contains: sodium 7 mg
- •
- store at 20-25°C (68-77°F)
Inactive ingredients
anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
Questions or comments?
Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
For most recent product information, visit www.dimetapp.com
Distributed by:
Pfizer, Madison, NJ 07940 USA
PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label
Children's
Dimetapp®
Multi-Symptom
Cold & Flu
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)
Relieves Nasal Symptoms
- •
- Stuffy Nose
- •
- Runny Nose
- •
- Sneezing
Plus Other Symptoms
- •
- Itchy, Watery Eyes
- •
- Cough
- •
- Fever, Headaches
- •
- Body Aches
Packaged with Tamper-Evident
bottle cap. Do Not Use if breakable
ring is separated or missing.
4 FL OZ (118 ml)
PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
NEW FORMULA
Children's
Dimetapp®
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)
Multi-Symptom
Cold & Flu
Relieves Nasal Symptoms
- •
- Stuffy Nose
- •
- Runny Nose
- •
- Sneezing
Plus Other Symptoms
- •
- Itchy, Watery Eyes
- •
- Cough
- •
- Fever, Headaches
- •
- Body Aches
4 FL OZ (118 ml)
alcohol-free • red grape flavor