Other
Drug Facts
Distributed by:
Foundation Consumer Healthcare, LLC
Pittsburgh, PA 15212
Dimetapp Tablet, Chewable
FDA Label NDC 69536-370
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foundation Consumer Healthcare for the product Dimetapp (NDC 69536-370). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Diphenhydramine HCl 12.5 mg
Otc - Purpose
| Active ingredients (in each chewable tablet) | Purposes |
| Diphenhydramine HCl 12.5 mg | Antihistamine/Cough suppresant |
Uses
- temporarily relieves:
- cough
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
- temporarily alleviates the intensity of coughing
Warnings
Warnings
Do Not Use
- to sedate a child or make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- glaucoma
- trouble urinating due to enlarged prostate gland
- 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
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a vehicle or operating machinery
- excitability may occur, expecially 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.
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
- chew or crush tablets completely before swallowing, do not swallow tablets whole
- do not take more than 6 doses in 24 hours
| age | dose |
| adults and children 12 years and over | take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours |
| children 6 to under 12 years | take 1 tablet every 4 hours not to exceed 6 tablets in 24 hours |
| children under 6 years | do not use |
Other Information
- store at 20-25°C (68-77°F)
- avoid high humidity
Inactive Ingredients
D&C red no.27 aluminum lake, D&C red no.30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue no.1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, modified corn starch, stearic acid, sucralose, sucrose
Questions Or Comments?
Call 1-888-594-0828weekdays 9 AM to 5PM EST
Principal Display Panel - 24 Ct Carton
CHILDREN'S
Dimetapp
DIPHENHYDRAMINE HCl, 12.5 mg
(Antihistamine/Cough Suppressant)
GREAT CHEWABLE TASTE
Cough & Allergy
Relieves + comforts:
- Cough
- Itchy throat
- Sneezing
- Runny nose
6+ years
24 CHEWABLE TABLETS
Grape-Flavored
* Please review the disclaimer below.
