ALLERGY AND STUFFY NOSE- chlorpheniramine maleate and phenylephrine hydrochloride liquid

Allergy and Stuffy Nose by

Drug Labeling and Warnings

Allergy and Stuffy Nose by is a Otc medication manufactured, distributed, or labeled by Accudial Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ALLERGY & STUFFY NOSE

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL, 1 teaspoonful)	Purposes
Chlorpheniramine maleate 1 mg	Antihistamine
Phenylephrine HCl 2.5 mg	Nasal decongestant

Uses

• temporarily relieves
  • itchy, watery eyes
  • runny nose
  • itchy nose or throat
  • sneezing
  • nasal and sinus congestion as may occur with a cold

Warnings

Do not use

• in a child under 4 years of age
• in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
• for the purpose of making your child sleepy

Ask a doctor before use if the child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• a breathing problem such as asthma or chronic bronchitis

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
• symptoms do not improve within 7 days or occur with a fever. These could be signs of a serious condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
• to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age.
• specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device.

Age	Dose
children under 4 years of age	do not use
children 4 to under 6 years of age	do not use unless directed by a doctor
children 6 to under 12 years of age	1-2 tsp. (5-10 mL)

Other information

• each teaspoonful contains: sodium 3 mg
• store at controlled room temperature 20°-25°C (68°-77°F)

Inactive ingredients

artificial flavor, benzoic acid, citric acid, disodium EDTA, FD&C yellow #6, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

Questions?

877-434-2036

PRINCIPAL DISPLAY PANEL - 118 mL Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

Allergy
& Stuffy Nose

ACCURATE DOSING
BY WEIGHT

Chlorpheniramine maleate
(Antihistamine)

Phenylephrine HCl
(Nasal Decongestant)

Itchy, Watery Eyes
Runny Nose
Stuffy Nose
Sneezing

For Ages 6 to under 12

Compares to
Children's Triaminic®
Cold & Allergy.

ORANGE
FLAVOR

4 FL. OZ.
(118 mL)
NDC: 45014-141-04

INGREDIENTS AND APPEARANCE

ALLERGY AND STUFFY NOSE 
chlorpheniramine maleate and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45014-141
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U)	Chlorpheniramine Maleate	1 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Orange (UNII: 5EVU04N5QU)
Benzoic Acid (UNII: 8SKN0B0MIM)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Edetate Disodium (UNII: 7FLD91C86K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Citrate (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45014-141-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/11/2009

Labeler - Accudial Pharmaceutical, Inc. (831999201)