LoHist PEB DM description, usages, side effects, indications, overdosage, supplying and lots more!

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LoHist PEB DM

Larken Laboratories, Inc.




FULL PRESCRIBING INFORMATION

In each 5 mL (1 teaspoonful)

Brompheniramine Maleate, USP 4 mg

Dextromethorphan HBr, USP 20 mg

Phenylephrine HCl, USP 10 mg

Antihistamine

Antitussive (cough suppressant)

Nasal decongestant

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
  • temporarily restores freer breathing through the nose

Do not use

  • to sedate a child or make a child sleepy
  • 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 two 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.
  • 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)
  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Do not exceed recommended dosage.

  • marked 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
  • 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.

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center immediately.

do not exceed 6 doses in a 24-hour period

Age Dose
Adults and children over 12 years of age 1 teaspoonsful (5 mL) every 4 hours
Children 6 to under 12 years of age 1/2 teaspoonsful (2.5 mL) every 4 hours
Children under 6 years of age Ask your doctor
  • store at 20°-25°C (68°-77°F)
  • very low sodium, contains 1 mg sodium per teaspoonful (5 mL)

Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring

Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

Figure 1: 16 oz Bottle Label

LoHist PEB DM

LoHist PEB DM

Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68047-341
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Brompheniramine Maleate BROMPHENIRAMINE 4 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 20 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
EDETATE DISODIUM
FD&C RED NO. 40
propylene glycol
water
saccharin sodium
sorbitol

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68047-341-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-01-06


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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