OTC Medication Information: Allergy Relief Complete

ALLERGY RELIEF COMPLETE- diphenhydramine hydrochloride tablet
WinCo Foods, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • itchy, watery eyes
    • runny nose

    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

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

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • 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 (1-800-222-1222) right away.

Directions

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use

Other information

  • each tablet contains: calcium 30 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions?

Call 800-824-1706 Monday — Friday 9am — 4pm MST

Principal Display Panel

WinCo™

FOODS

*Compare to the active ingredient in BENADRYL® Allergy Ultratab®

COMPLETE

Allergy

Relief

DIPHENHYDRAMINE HCl 25 mg/

ANTIHISTAMINE

Relieves: Sneezing,

Runny Nose,

Itchy, Watery Eyes

& Itchy Throat

Easy to Swallow

100

Minitabs

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed by

JOHNSON & JOHNSON CORPORATION, distributor of BENADRYL® Allergy Ultratab®.

50844 REV1016A32912 WF1801

100% SATISFACTION GUARANTEE

Comments & Questions? 800-824-1706

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

Winco 44-329
(click image for full-size original)

Winco 44-329

ALLERGY RELIEF COMPLETE diphenhydramine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C RED NO. 27
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Product Characteristics
Color PINK Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 44;329
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67091-200-24 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET in 1 BLISTER PACK This package is contained within the CARTON (67091-200-24)
2 NDC:67091-200-10 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET in 1 BOTTLE This package is contained within the CARTON (67091-200-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/02/1990
Labeler — WinCo Foods, LLC (056098817)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK (67091-200)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE (67091-200)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 MANUFACTURE (67091-200), PACK (67091-200)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 PACK (67091-200)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 PACK (67091-200)

Revised: 01/2020 WinCo Foods, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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