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SPL v11
SPL
SPL Set ID c3369d67-b945-4100-9248-178ab4f3a44a
Route
oral
Published
Effective Date 2012-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chlorpheniramine (4 mg) phenylephrine (10 mg)
Inactive Ingredients
anhydrous citric acid d&c red no. 33 edetate disodium glycerin methylparaben propylene glycol propylparaben water saccharin sodium trisodium citrate dihydrate

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
otc monograph drug active Since 2011-01-06

Purpose

Chlorpheniramine Maleate Antihistamine Phenylephrine HCl Nasal decongestant

Description

Drug Facts


Medication Information

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.
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
  • temporarily restores freer breathing through the nose
Purpose

Chlorpheniramine Maleate Antihistamine

Phenylephrine HCl Nasal decongestant

Directions

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
Other Information
  • store at 20°-25°C (68°-77°F)
  • very low sodium, contains 5 mg sodium per 5 mL teaspoonful
Inactive Ingredients

bubblegum flavoring, citric acid, D&C Red #33, edetate disodium, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, and sodium citrate dihydrate

Description

Drug Facts

Principal Display Panel

Figure 1: 16 oz. Bottle Label

Section 42229-5

Drug Facts

Active Ingredients

(In each 5 mL teaspoonful)

Chlorpheniramine Maleate, USP 4 mg

Phenylephrine HCl, USP 10 mg

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

Structured Label Content

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.
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
  • temporarily restores freer breathing through the nose
Purpose

Chlorpheniramine Maleate Antihistamine

Phenylephrine HCl Nasal decongestant

Directions

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
Other Information
  • store at 20°-25°C (68°-77°F)
  • very low sodium, contains 5 mg sodium per 5 mL teaspoonful
Inactive Ingredients

bubblegum flavoring, citric acid, D&C Red #33, edetate disodium, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, and sodium citrate dihydrate

Principal Display Panel

Figure 1: 16 oz. Bottle Label

Section 42229-5 (42229-5)

Drug Facts

Active Ingredients

(In each 5 mL teaspoonful)

Chlorpheniramine Maleate, USP 4 mg

Phenylephrine HCl, USP 10 mg

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.
  • 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.
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
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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