Kroger Allergy Relief

Kroger Allergy Relief
SPL v2
SPL
SPL Set ID 36705f6c-bfac-319a-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2016-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrilamine (50 mg) Chlophedianol (25 mg)
Inactive Ingredients
Anhydrous Citric Acid Propylene Glycol Glycerin Water Sodium Citrate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-04-07

Description

Active ingredients (in each 30 mL (2 TBSP)) Chlophedianol HCl 25 mg Pyrilamine Maleate 50 mg


Medication Information

Warnings and Precautions

Warnings

Do not exceed recommended dosage.

Indications and 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
Dosage and 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
Description

Active ingredients (in each 30 mL (2 TBSP)) Chlophedianol HCl 25 mg Pyrilamine Maleate 50 mg

Section 44425-7

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
Section 50565-1

Keep out of reach of children.

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

Section 50566-9

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
Section 50567-7

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
Section 50568-5

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

Section 50569-3

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
Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions or comments?

1-800-632-6900

Section 53414-9

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

Section 55105-1

Purpose

Cough suppressant

Antihistamine

Section 55106-9

Active ingredients

(in each 30 mL (2 TBSP))

Chlophedianol HCl 25 mg

Pyrilamine Maleate 50 mg

Kroger Allergy Relief 8 Fl Oz (237 Ml) Bottle Label


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

Do not exceed recommended dosage.

Section 44425-7 (44425-7)

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
Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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
Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

Questions or comments?

1-800-632-6900

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant

Antihistamine

Section 55106-9 (55106-9)

Active ingredients

(in each 30 mL (2 TBSP))

Chlophedianol HCl 25 mg

Pyrilamine Maleate 50 mg

Kroger Allergy Relief 8 Fl Oz (237 Ml) Bottle Label (KROGER ALLERGY RELIEF 8 fl oz (237 mL) Bottle Label)


Advanced Ingredient Data


Raw Label Data

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