CHILDRENS DIMETAPP MULTISYMPTOM COLD AND FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
Richmond Division of Wyeth
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Children's Dimetapp Multi-Symptom Cold & Flu
(acetaminophen, chlorpheniramine maleate, dextromethorphan HBr, and phenylephrine HCl)
ACTIVE INGREDIENTS (IN EACH 5 ML TSP)
Chlorpheniramine maleate, USP 1 mg
USES
- temporarily relieves these symptoms associated with a cold, or flu:
- headache
- sore throat
- fever
- minor aches and pains
- temporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a cold
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- runny nose
- temporarily restores freer breathing through the nose
WARNINGS
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if user takes
- more than 5 doses in any 24-hour period, which is the maximum daily amount
- with other drugs containing acetaminophen
- 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 user is 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.
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 any other pain reliever/fever reducer
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- marked drowsiness may occur
- 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
- user gets nervous, dizzy, or sleepless
- 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
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- new symptoms occur
DIRECTIONS
- do not take more than 5 doses in any 24-hour period
- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
| age | dose |
|---|---|
| adults and children 12 years and over | 4 teaspoons every 4 hours |
| children 6 to 12 years | 2 teaspoons every 4 hours |
| children under 6 years | do not use |
OTHER INFORMATION
- each teaspoon contains: sodium 2 mg
- store at 20-25°C (68-77°F)
- dosage cup provided
INACTIVE INGREDIENTS
anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Children's Dimetapp Multi-Symptom Cold & Flu
Acetaminophen (Pain Reliever/Fever Reducer)
Chlorpheniramine Maleate (Antihistamine)
Dextromethorphan HBr (Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
- Stuffy Nose
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
- Cough
- Fever, Headaches
- Body Aches
alcohol-free ∙ red grape flavor
For most recent product information, visit www.dimetapp.com
We pledge to you that Dimetapp products contain only high quality ingredients and meet strict standards of quality and safety. You can trust Dimetapp products for your family.
PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org
Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.
| CHILDRENS DIMETAPP MULTISYMPTOM COLD AND FLU
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid |
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| Labeler - Richmond Division of Wyeth (829390835) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Fareva Richmond, Inc. | 969523245 | ANALYSIS(0031-2246) , LABEL(0031-2246) , MANUFACTURE(0031-2246) , PACK(0031-2246) , RELABEL(0031-2246) , REPACK(0031-2246) | |