LOHIST PSB  - brompheniramine maleate and pseudoephedrine hydrochloride liquid 
Larken Laboratories, Inc.

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LoHist PSB

Drug Facts

Active Ingredients

In each 5 mL (1 teaspoonful) clear, cherry flavored liquid
Brompheniramine maleate, USP 4 mg
Pseudoephedrine HCl, USP 20 mg

Purpose

Brompheniramine Maleate          Antihistamine
Pseudoephedrine HCl                    Nasal decongestant

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis):

• 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 product.

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

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
• symptoms do not improve within 7 days, or are accompanied by fever

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, bitter masking agent, cherry flavoring, citric acid, glycerin, polyethylene glycol, purified water, saccharin sodium, and sorbitol solution

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: Product Label (front side)

LOHIST PSB  brompheniramine maleate and pseudoephedrine hydrochloride   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68047-342 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 4 mg  in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 20 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength BENZOIC ACID   ANHYDROUS CITRIC ACID   GLYCERIN   POLYETHYLENE GLYCOL 400   WATER   SACCHARIN SODIUM   SORBITOL

Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68047-342-16 473 mL In 1 BOTTLE None

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

Revised: 01/2011Larken Laboratories, Inc.