Dimetapp Solution
FDA Label NDC 69536-345

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 69536-345). 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 - 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ 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

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