LOHIST D - chlorpheniramine maleate and pseudoephedrine hydrochloride liquid 
Larken Laboratories, Inc.

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LoHist•D

Drug Facts

Active ingredients (per 5 mL liquid)

Chlorpheniramine Maleate, USP 2.0 mg

Pseudoephedrine HCl, USP 30 mg

Purpose

Chlorpheniramine Maleate - Antihistamine

Pseudoephedrine HCl - Nasal decongestant

Uses

• Temporarily relieves these symptoms due to common cold, hay fever or other upper respiratory allergies or infections
• Watery eyes
• Runny nose
• Sneezing
• Nasal and sinus congestion

Warnings

Do not use

• In a child under 2 years of age
• 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.

Ask a doctor before use if you have

• Heart disease
• High blood pressure
• Thyroid disease
• Diabetes
• Glaucoma
• Gastrointestinal obstruction
• Trouble urinating due to enlarged prostate gland
• Breathing problems such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

When using this product

• do not use more than directed
• 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

Stop use and ask a doctor if

• you get nervous, dizzy or have sleeplessness
• symptoms do not improve or are accompanied by fever, rash or persistent headache. These could be sign of a serious condition.

If pregnant or breast-feeding,

• ask a health professional before use.

Keep out of reach of children.

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

Directions

• Adults and children over 12 years of age: 2 teaspoonsful (10 mL) every 4 to 6 hours
• Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours
• Children 2 to under 6 years of age: Ask your doctor
• Children under 2 years of age: Not Recommended.
• Do not exceed 6 doses in a 24 hour period.

Other information

• store at 20°- 25°C (68°- 77°F)

Inactive ingredients

Cherry flavoring, methylparaben, polyethylene glycol, propylparaben, purified water, saccharin sodium, and sorbitol

Questions or Comments?

Call weekdays from 9 AM to 4PM CST at 1-888-527-5522 or go to http://www.larkenlabs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68047-120-16

2 mg Chlorpheniramine Maleate & 30 mg Pseudoephedrine HCl liquid

ANTIHISTAMINE & NASAL DECONGESTANT

Figure 1: Container label, front side

Figure 2: Container label, back side

LOHIST  D chlorpheniramine maleate / pseudoephedrine hcl   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68047-120 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg  in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength CHERRY   METHYLPARABEN   POLYETHYLENE GLYCOL   PROPYLPARABEN   WATER   SACCHARIN SODIUM   SORBITOL

Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68047-120-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/15/2003

Labeler - Larken Laboratories, Inc. (791043719)

Registrant - Larken Laboratories, Inc. (791043719)

Establishment
Name	Address	ID/FEI	Operations
Sovereign Pharmaceuticals, LLC		623168267	MANUFACTURE

Revised: 03/2010Larken Laboratories, Inc.