Label: ALLERGY RELIEF- diphenhydramine hydrochloride capsule
- NDC Code(s): 11822-0190-1, 11822-0190-2, 11822-0190-8
- Packager: Rite Aid
- 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 banded capsule)
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:
runny nose sneezing
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
excitability 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 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age
- Other information
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
protect from moisture
see end flap for expiration date and lot number
- Inactive ingredients
butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, propylparaben, polysorbate 80, silica gelClose
- Questions or comments?
- Principal Display Panel
*Compare to the active ingredient of Extra Strength Benadryl®
diphenhydramine HCl 25 mg
itchy, watery eyes
25 mg EACH
EACH CAPSULE INDIVIDUALLY BANDED FOR YOUR PROTECTION
TAMPER EVIDENT: PRODUCT SEALED IN PLASTIC STRIPS, CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
Rite Aid Corporation
30 Hunter Lane, Camp Hill, PA 17011
Rite Aid 44-190
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0190 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 BUTYLPARABEN D&C RED NO. 28 FD&C BLUE NO. 1 GELATIN LACTOSE MAGNESIUM STEARATE METHYLPARABEN PROPYLPARABEN POLYSORBATE 80 Product Characteristics Color PINK Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 44;107 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0190-2 1 in 1 CARTON 1 48 in 1 BLISTER PACK 2 NDC:11822-0190-8 1 in 1 CARTON 2 24 in 1 BLISTER PACK 3 NDC:11822-0190-1 1 in 1 CARTON 3 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part336 03/15/1990 Labeler - Rite Aid (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(11822-0190) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(11822-0190)