![M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY]](https://medic.hrt.org//dailymed/images/fce1a6e4-cda3-462e-a853-049eabe4441e/MM1.jpg)
![M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY]](https://medic.hrt.org//dailymed/images/fce1a6e4-cda3-462e-a853-049eabe4441e/MM2.jpg)
| NDC | 12830-754-12, 12830-754-30 |
| Set ID | fce1a6e4-cda3-462e-a853-049eabe4441e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | R.A. McNeil Company |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Drug Facts
Active ingredients
(in each 5 mL teaspoonful)
Brompheniramine Maleate 1.33 mgCodeine Phosphate 6.33 mg
Close
(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
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
- new symptoms occur
CloseKeep out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
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.
Close - Other information
- Inactive ingredients
citric acid, cotton candy flavor, FD&C Red #40, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol
Close - Questions? Comments?
- 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 PEAntihistamine · Antitussive
· Nasal Decongestant
Sugar Free · Alcohol Free
CV
EACH 5 mL (1 TEASPOONFUL)CONTAINS:
Brompheniramine Maleate ..........................1.33 mgCodeine 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.
Close
- INGREDIENTS AND APPEARANCE
M-END PE
codeine phosphate, phenylephrine hydrochloride, brompheniramine maleate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12830-754 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 6.33 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 3.33 mg in 5 mL BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 1.33 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor COTTON CANDY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12830-754-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2014 2 NDC:12830-754-30 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/11/2008 Labeler - R.A. McNeil Company (008305220) Registrant - Woodfield Pharmaceutical, LLC (079398730) CloseEstablishment Name Address ID/FEI Business Operations Woodfield Pharmaceutical, LLC 079398730 manufacture(12830-754)