LOHIST D- chlorpheniramine maleate / pseudoephedrine hcl liquid

LoHist by

Drug Labeling and Warnings

LoHist by is a Otc medication manufactured, distributed, or labeled by Larken Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

(In each 5 mL teaspoonful)

Chlorpheniramine Maleate, USP 2 mg

Pseudoephedrine HCl, USP 30 mg

Purpose

Chlorpheniramine Maleate Antihistamine

Pseudoephedrine HCl Nasal decongestant

Uses

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

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies.
• temporarily restores freer breathing through the nose

Warnings

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 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

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

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

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

Directions

Do not exceed 4 doses in a 24-hour period

• Age: Dose
• 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 under 6 years of age: Ask your doctor

Other information

• store at 20°-25°C (68°-77°F)
• very low sodium, contains less than 1 mg sodium per 5 mL teaspoonful

Inactive ingredients

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

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.

Package Label, Principal Display Panel

Figure 1: 16 oz. bottle label

INGREDIENTS AND APPEARANCE

LOHIST   D
chlorpheniramine maleate / pseudoephedrine hcl liquid

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68047-120-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/15/2003

Labeler - Larken Laboratories, Inc. (149484540)

Registrant - Larken Laboratories, Inc. (149484540)