DIMETAPP MULTI-SYMPTOM COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution
Foundation Consumer Brands
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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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
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.
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
- 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.
If pregnant or breast-feeding, ask a health professional before use.
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
Distributed by:
Foundation Consumer Brands, LLC, Pittsburgh, PA 15212
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
CHILDREN'S
Dimetapp®
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)
PHARMACIST
RECOMMENDED
Multi-
Symptom
Cold & Flu
Relieves + comforts:
- ✓
- Fever
- ✓
- Head & body aches
- ✓
- Cough
- ✓
- Stuffy, runny nose
- ✓
- Sneezing
- ✓
- Sore throat
6+
YRS
4 FL OZ
(118 mL)
Red Grape Flavor • Alcohol Free