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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Drug Facts
Active ingredients (in each 10 ml)
Acetaminophen, USP 320 mg
Diphenhydramine HCl, USP 12.5 mg
Phenylephrine HCl, USP 5 mg
Uses
- •
- temporarily relieves these symptoms associated with a cold, or flu:
- •
- headache
- •
- sore throat
- •
- fever
- •
- minor aches and pains
- •
- 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
- •
- itchy, watery eyes
- •
- runny nose
- •
- 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
- •
- 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
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
- •
- 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
- •
- 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
Directions
- •
- 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
- •
- 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 |
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
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
| CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |