FDA Label for Dimetapp Multi-symptom Cold And Flu
View Indications, Usage & Precautions
- 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
Dimetapp Multi-symptom Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Foundation Consumer Brands. 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
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 Brands, 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 |
| Phenylephrine HCl, 5 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- nasal congestion
- sore throat
- cough
- runny nose
- itching of the nose or throat
- sneezing
- temporarily reduces fever
- temporarily restores freer breathing through the nose
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
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- 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 any other oral nasal decongestant or stimulant
- 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
- nervousness, dizziness or sleeplessness occurs
- pain, cough, or nasal congestion 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 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 7 mg and potassium 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
Principal Display Panel - 118 Ml Bottle Carton
Children's
Dimetapp®
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)
Multi-Symptom
Cold & Flu
Relieves Nasal Symptoms
✓ Stuffy Nose✓ Runny Nose✓ Sneezing✓ Cough✓ Fever, Headaches✓ Body Aches
Plus Other Symptoms
4 FL OZ (118 mL) alcohol-free • red grape flavor
* Please review the disclaimer below.