Dimetapp Solution
FDA Label NDC 69536-335

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 69536-335). 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, liver warning, sore throat warning, do not use, ask a doctor before use if user has, ask a doctor or pharmacist before use if user is, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Uses

→ Liver Warning

→ Sore Throat Warning

→ Do Not Use

→ Ask A Doctor Before Use If User Has

→ Ask A Doctor Or Pharmacist Before Use If User Is

→ 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

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Distributed by:
Foundation Consumer Healthcare, LLC, Pittsburgh, PA 15212

Otc - Purpose

Active ingredients (in each 10 mL)	Purposes
Acetaminophen, 320 mg	Pain reliever/fever reducer
Diphenhydramine HCl, 12.5 mg	Antihistamine/cough suppressant

Uses

temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough
- runny nose
- sneezing
- temporarily alleviates the intensity of coughing
- temporarily reduces fever

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 6 doses in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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
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
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 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

pain or cough 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
new symptoms occur
cough comes back or occurs with fever, rash or headache that lasts. 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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

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 do not take more than 6 doses in any 24-hour period
children 6 to under 12 years	10 mL every 4 hours do not give more than 5 doses in any 24-hour period
children under 6 years	do not use

Other Information

each 10 mL contains: sodium 6 mg
store at 20-25°C (68-77°F)
read and keep carton

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