Label: COMPLETE ALLERGY- diphenhydramine hydrochloride tablet
- NDC Code(s): 64092-830-24
- Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each tablet)
Diphenhydramine HCl 25 mgClose
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
itchy, watery eyes
itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
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
trouble urinating due to an enlarged prostate gland
When using this product
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
may occur, especially in children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
take every 4 to 6 hours
do not take more than 6 doses in 24 hours
adults and children 12 years of age and over
1 to 2 tablets children 6 to under 12 years of age 1 tablet children under 6 years of age do not use this product in children under 6 years of age
- Other information
store at controlled room temperature 15°-30°C (59°-86°F)
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 dioxideClose
- Questions or comments?
- Principal Display Panel
Diphenhydramine HCl 25 mg
• Runny Nose •Sneezing
• Itchy Troat •Itchy, Watery Eyes
*Compare to the active ingredient in Benadryl® Allergy Ultratab®
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®.
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING
- INGREDIENTS AND APPEARANCE
diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-830 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C RED NO. 27 (UNII: 2LRS185U6K) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK Score no score Shape CLOVER Size 11mm Flavor Imprint Code 44;329 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64092-830-24 1 in 1 CARTON 1 24 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 03/02/1990 Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(64092-830) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(64092-830)