KROGER ALLERGY RELIEF- chlophedianol hydrochloride, pyrilamine maleate liquid

Kroger Allergy Relief by

Drug Labeling and Warnings

Kroger Allergy Relief by is a Otc medication manufactured, distributed, or labeled by THE KROGER CO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 30 mL (2 TBSP))

Chlophedianol HCl 25 mg

Pyrilamine Maleate 50 mg

PURPOSE

Purpose

Cough suppressant

Antihistamine

INDICATIONS & USAGE

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• cough due to minor throat and bronchial irritation
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes

WARNINGS

Warnings

Do not exceed recommended dosage.

ASK DOCTOR

Ask a doctor before use if you have

• a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
• a cough that occurs with too much phlegm (mucus)
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• a sodium restricted diet

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

WHEN USING

When using this product

• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

STOP USE

Stop use and ask a doctor if:

• nervousness, dizziness or sleeplessness occurs
• symptoms do not improve within 7 days, tends to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
• new symptoms occur

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

• Do not exceed recommended dosage.
• Do not take more than 4 doses in any 24-hr period.
• Use enclosed dose cup
• Keep dosage cup with product
• TBSP=tablespoon
• mL=milliliter
• Adults and children 12 years and over: 30 mL (2 TBSP) every 6-8 hours
• Children under 12: do not use

STORAGE AND HANDLING

Other information

• each 30 mL (2 TBSP) contains: Sodium 13 mg
• tamper evident: Do not use if foil seal under cap is broken or missing
• read all product information before using
• store at 68° to 86°F (20° to 30°C).
• avoid excessive heat and humidity

INACTIVE INGREDIENT

Inactive ingredients

Anhydrous citric acid, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

QUESTIONS

Questions or comments?

1-800-632-6900

KROGER ALLERGY RELIEF 8 fl oz (237 mL) Bottle Label

INGREDIENTS AND APPEARANCE

KROGER ALLERGY RELIEF 
chlophedianol hydrochloride, pyrilamine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-773
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	50 mg  in 30 mL
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	25 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-773-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/07/2016

Labeler - THE KROGER CO (006999528)