Otc - Active Ingredient
Active ingredients
(in each 30 mL (2 TBSP))
Chlophedianol HCl 25 mg
Pyrilamine Maleate 50 mg
Kroger Allergy Relief
FDA Label NDC 30142-773
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co for the product Kroger Allergy Relief (NDC 30142-773). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Otc - 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
Otc - 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
Otc - Questions
Questions or comments?
1-800-632-6900
Kroger Allergy Relief 8 Fl Oz (237 Ml) Bottle Label
* Please review the disclaimer below.
