FDA Label for Dimetapp Nighttime Cold And Cough
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON
Dimetapp Nighttime Cold And Cough Product Label
The following document was submitted to the FDA by the labeler of this product Foundation Consumer Healthcare. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by:
Foundation Consumer Healthcare, LLC
Pittsburgh, PA 15212
Otc - Purpose
| Active ingredient (in each 10 mL) | Purpose |
|---|---|
| Diphenhydramine HCl, 12.5 mg | Antihistamine/cough suppressant |
Uses
- temporarily relieves:
- cough
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever (or other respiratory allergies)
- relieves the impluse to cough to help you sleep
Do Not Use
- to sedate a child or to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- 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 sedatives or tranquilizers
When Using This Product
- do not use more than directed
- may cause marked drowsiness
- 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
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
- 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)
- do not refrigerate
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 1-888-594-0828 weekdays 9 AM to 5 PM EST
Principal Display Panel - 118 Ml Bottle Carton
NEW FORMULA
CHILDREN'S
Dimetapp
®
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHARMACIST
RECOMMENDED
Nighttime
Cold &
Cough
Relieves + comforts:
- Runny nose
- Itchy, watery eyes
- Sneezing
- Cough
6+
YRS
4 FL OZ
(118 mL)
Grape Flavor • Alcohol Free
* Please review the disclaimer below.
