LOHIST PEB DM
-
brompheniramine maleate,
dextromethorphan hydrobromide and
phenylephrine hydrochloride liquid
Larken Laboratories, Inc.
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LoHist PEB DMDrug Facts
Active Ingredients
In each 5 mL (1 teaspoonful) pink, bubblegum flavored liquid
Brompheniramine Maleate, USP 4 mg
Dextromethorphan HBr, USP 20 mg
Phenylephrine HCl, USP 10 mg
Purpose
Brompheniramine Maleate Antihistamine
Dextromethorphan HBr Antitussive
Phenylephrine HCl Nasal decongestant
Uses
Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- cough due to minor throat and bronchial irritation
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis.
- Temporarily restores freer breathing through the nose
Warnings
Do not exceed recommended dosage.
Do not use
- 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 drug.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking any other nasal decongestant or stimulant
- taking sedatives or tranquilizers
When using this product
- drowsiness may occur
- avoid alcoholic beverages
- 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 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.
If pregnant or breast-feeding
- ask a health professional before use.
Keep out of the reach of children
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Directions
Do not exceed 6 doses in a 24-hour period
| Age | Dose |
| Adults and children over 12 years of age | 1 teaspoonful (5 mL) every 4 to 6 hours |
| Children 6 to under 12 years of age | 1/2 teaspoonful (2.5 mL) every 4 to 6 hours |
| Children under 6 years of age | Ask your doctor |
Other Information
store at 20°-25°C (68°-77°F)
Inactive Ingredients
Benzoic acid, editate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring
Questions or Comments
Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.
Principal Display Panel
Figure 1: 16 oz Bottle Label
| LOHIST PEB DM
brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 01/06/2011 | |
| Labeler - Larken Laboratories, Inc. (791043719) |
| Registrant - Larken Laboratories, Inc. (791043719) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sovereign Pharmaceuticals, LLC | 623168267 | MANUFACTURE | |