Indications and 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
Dimetapp
- Manufacturer
- Foundation Consumer Healthcare
- Effective date
- 2025-10-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:39:48
Label at a glance#
ProductDimetapp Multi-Symptom Cold and Flu
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
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...
Storage and handling
each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F) read and keep carton
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| 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
Warnings
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.
SPL UNCLASSIFIED SECTION
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.
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 SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
Questions or comments?
Call 1-888-594-0828 weekdays 9 AM to 5 PM EST
SPL UNCLASSIFIED SECTION
Distributed by:
Foundation Consumer Healthcare, LLC, Pittsburgh, PA 15212
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
NEW FORMULA
CHILDREN'S
Dimetapp
®
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHARMACIST
RECOMMENDED
Multi-
Symptom
Cold & Flu
Relieves + comforts:
- Fever
- Head & body aches
- Cough
- Runny nose
- Sneezing
- Sore throat
6+
YRS
4 FL OZ
(118 mL)
Red Grape Flavor • Alcohol Free
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2683420 | acetaminophen 320 MG / diphenhydrAMINE HCl 12.5 MG in 10 mL Oral Solution | PSN | 2 |
| 2683420 | acetaminophen 32 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Solution | SCD | 2 |
| 2683420 | acetaminophen 320 MG / diphenhydramine HCl 12.5 MG per 10 mL Oral Solution | SY | 2 |
| 2683420 | APAP 32 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Solution | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0850026660050 | GTIN-13: 0850026660050 EAN-13: 0850026660050 GTIN-12: 850026660050 UPC-A: 850026660050 GTIN storage (14 digits): 00850026660050 | MultiSymptom-01.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69536-335-04 | DimetappMulti-Symptom Cold and Flu | 118 mL in 1 BOTTLE | SOLUTION | 118 | 2 | |
| 69536-335-04 | DimetappMulti-Symptom Cold and Flu | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 69536-335-08 | DimetappMulti-Symptom Cold and Flu | 2 in 1 CARTON | SOLUTION | 2 | 2 | |
| 69536-335-08 | DimetappMulti-Symptom Cold and Flu | 118 mL in 1 BOTTLE | SOLUTION | 118 | 2 |
Products#
Every source-derived product name is available through these pages.
- Dimetapp Multi-Symptom Cold and Flu
- acetaminophen, diphenhydramine hydrochloride
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- FD&C RED NO. 40
- GLYCERIN
- MENTHOL, UNSPECIFIED FORM
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYL GALLATE
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE, UNSPECIFIED FORM
- SORBITOL
- SUCRALOSE
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69536-335 | 69536-335-04, 69536-335-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2024-06-01 | full-release | 2026-06-01 00:13:10 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dimetapp Multi-Symptom Cold and Flu | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 178fe95b-e1ed-43b2-e063-6294a90a7a78 | 2025-10-24 | Warnings | 69536-335-08 69536-335-04 69536-335 69536033504 69536033508 41e82253-443b-2119-e063-6394a90a9912 178fe95b-e1ed-43b2-e063-6294a90a7a78 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.