Active Ingredient (In Each Tablet)
Chlorpheniramine maleate 4 mg
Allergy Relief Tablet
FDA Label NDC 67091-203
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Allergy Relief (NDC 67091-203). 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 active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Do Not Use
to make a child sleepy.
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- alcohol, sedatives, and tranquilizers may increase drowsiness
- drowsiness may occur
- use caution when driving a motor vehicle or operating machinery
- avoid alcoholic beverages
- excitability may occur, especially in children
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take every 4 to 6 hours, or as directed by a doctor
adults and children 12 | 1 tablet. Do not exceed 6 tablets |
| children 6 to under 12 years | 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. |
| children under 6 years | do not use |
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from excessive moisture
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose
Questions?
Call 1-800-824-1706 Monday - Friday 9am-4pm MST
Principal Display Panel
WinCo®
FOODS
4-HOUR
Allergy
Relief
Relieves: Sneezing,
Runny Nose,
Itchy, Watery Eyes
& Itchy Throat
CHLORPHENIRAMINE
MALEATE 4 mg/
ANTIHISTAMINE
24
Tablets
DISTRIBUTED BY:
WINCO FOODS, LLC,
BOISE, ID 83704
50844 REV0419A19408 WF2007
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
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Comments & Questions? 800-824-1706
www.wincofoods.com
Winco 44-194 (Winco 44 194 1)
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