M-END PE- codeine phosphate, phenylephrine hydrochloride, brompheniramine maleate liquid
R.A. McNeil Company
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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Drug Facts
Active ingredients
(in each 5 mL teaspoonful)
Brompheniramine Maleate 1.33 mg
Codeine Phosphate 6.33 mg
(WARNING: May be habit-forming)
Phenylephrine Hydrochloride 3.33 mg
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- nasal congestion
- itching of nose or throat
- runny nose
- itchy, watery eyes
- sneezing
- reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
Do not use this product
- 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
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- chronic pulmonary disease or shortness of breath, or children who are taking other drugs
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
When using this product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- may cause or aggravate constipation
Directions
Do not exceed recommended dosage.
|
Adults and children 12 years of age and over: |
3 teaspoonfuls every 4 to 6 hours, not to exceed 18 teaspoonfuls in a 24 hour period |
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Children 6 to under 12 years of age: |
1 1/2 teaspoonfuls every 4 to 6 hours, not to exceed 9 teaspoonfuls in a 24 hour period |
|
Children under 6 years of age | Not recommended for use |
A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
Inactive ingredients
citric acid, cotton candy flavor, FD&C Red #40, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol
Product Packaging
The packaging below represents the labeling currently used.
Principal display panel and side panel for 354 mL label:
NDC 12830-0754-12
M-END PE
Antihistamine · Antitussive
· Nasal Decongestant
Sugar Free · Alcohol Free
CV
EACH 5 mL (1 TEASPOONFUL)
CONTAINS:
Brompheniramine Maleate ..........................1.33 mg
Codeine Phosphate.......................................6.33 mg
(WARNING: May be habit-forming.)
Phenylephrine Hydrochloride.......................3.33 mg
Cotton Candy Flavor
12 fl. oz. (354 mL)
Mfg. for:
R.A. McNeil Company
Chattanooga, TN 37406-3738
Rev. 10/14
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
This package not intended for dispensing to the patient.
| M-END
PE
codeine phosphate, phenylephrine hydrochloride, brompheniramine maleate liquid |
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| Labeler - R.A. McNeil Company (008305220) |