Lohist D

Lohist D
SPL v11
SPL
SPL Set ID 93c9ad4f-3376-48c2-8276-0375663acd01
Route
ORAL
Published
Effective Date 2025-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (2 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
Methylparaben Polyethylene Glycol 400 Propylparaben Water Saccharin Sodium Anhydrous Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-09-15

Description

Drug Facts

Purpose

Chlorpheniramine Maleate Antihistamine Pseudoephedrine HCl Nasal decongestant


Medication Information

Purpose

Chlorpheniramine Maleate Antihistamine

Pseudoephedrine HCl Nasal decongestant

Description

Drug Facts

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
Section 42229-5

Drug Facts

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.
Directions

Do not exceed 4 doses in a 24-hour period

Age Dose
Adults and children over 12 years of age 2 teaspoonfuls (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
Active Ingredients

(In each 5 mL teaspoonful)

Chlorpheniramine Maleate, USP 2 mg

Pseudoephedrine HCl, USP 30 mg

Inactive Ingredients

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

Questions Or Comments?

Call 1-601-855-7678 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

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.

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
Package Label, Principal Display Panel

Figure 1:16 oz. bottle label

Ask A Doctor Or Pharmacist Before Use If You Are.
  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Purpose

Chlorpheniramine Maleate Antihistamine

Pseudoephedrine HCl Nasal decongestant

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.
Directions

Do not exceed 4 doses in a 24-hour period

Age Dose
Adults and children over 12 years of age 2 teaspoonfuls (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 (Other information)
  • store at 20°-25°C (68°-77°F)
  • very low sodium, contains less than 1 mg sodium per 5 mL teaspoonful
Active Ingredients

(In each 5 mL teaspoonful)

Chlorpheniramine Maleate, USP 2 mg

Pseudoephedrine HCl, USP 30 mg

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-601-855-7678 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

When Using This Product (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 (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 (If pregnant or breast feeding)

ask a health professional before use.

Keep Out of the Reach of Children (Keep out of the reach of children)

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

Ask A Doctor Before Use If You Have (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
Package Label, Principal Display Panel

Figure 1:16 oz. bottle label

Ask A Doctor Or Pharmacist Before Use If You Are. (Ask a doctor or pharmacist before use if you are.)
  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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