CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION- diphenhydramine hcl, phenylephrine hcl liquid
GlaxoSmithKline Consumer Healthcare Holdings (US) 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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ACTIVE INGREDIENTS (IN EACH 10 ML)
Diphenhydramine HCl, USP 12.5 mg
Phenylephrine HCl, USP 5 mg
PURPOSES
Antihistamine/Cough suppressant
Nasal decongestant
USES
- •
- temporarily relieves these symptoms occurring with a cold, hay fever, or other upper respiratory allergies:
- •
- nasal congestion
- •
- cough
- •
- runny nose
- •
- sneezing
- •
- itchy, watery eyes
- •
- itching of the nose or throat
WARNINGS
Do not use
- •
- to sedate a child or to make a child sleepy
- •
- 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 product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- •
- 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 you are
- •
- taking any other oral nasal decongestant or stimulant
- •
- 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
- •
- you get nervous, dizzy, or sleepless
- •
- symptoms do not get better within 7 days or are accompanied by fever
- •
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
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.
DIRECTIONS
- •
- do not take more than 6 doses in any 24-hour period
- •
- do not exceed recommended dosage
- •
- 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 under 12 years
|
10 ml every 4 hours
|
children under 6 years
|
do not use
|
OTHER INFORMATION
- •
-
each 10 ml contains: sodium 8 mg
- •
- store at 20 -25°C (68 -77°F)
INACTIVE INGREDIENTS
anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, 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
PRINCIPAL DISPLAY PANEL
NDC 0031-2247-13
Children's
Dimetapp®
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)
Nighttime
Cold &
Congestion
Relieves Nasal Symptoms
- •
- Stuffy Nose
- •
- Runny Nose
- •
- Sneezing
Plus Other Symptoms
- •
- Itchy, Watery Eyes
- •
- Cough
For Ages
6 Yrs.
& Over
4 FL OZ (118 ml) grape flavor