20e164b8-4cbc-cf3f-e063-6394a90a9d0c
20e164b8-4cbc-cf3f-e063-6394a90a9d0c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Antihistamine
Description
Diphenhydramine HCl 25 mg
Medication Information
Active Ingredient
Diphenhydramine HCl 25 mg
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itchy nose or throat
- temporarily relieves these symptoms of the common cold:
- runny nose
- sneezing
Purpose
Antihistamine
Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
Adults and children 12 years and over:1 or 2 caplets
Children 6 to under 12 years of age:1 caplet
Children under 6 years of age: do not use
Other Information
- Each caplet contains:Calcium 23.52 mg
- store at controlled room temperature 20°-25°C (68°-77°F)
- read all product information before using.
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients
Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl alcohol, Titanium dioxide, Talc
Description
Diphenhydramine HCl 25 mg
Section 42229-5
Distributed by:
Advanced Rx LLC
1942 NE 163rd St North Miami Beach,
FL 33162 U.S.A.
MADE IN THE USA
Section 51945-4
NDC 80513-722-06
Compare to Benadryl ®Allergy Ultratab ®active ingredient*
ALLERGY RELIEF
DIPHENHYDRAMINE HCl 25 mg
ANTIHISTAMINE
RELIEVES:
Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat
600
MINI TABLETS
*This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl ®Allergy Ultratab ®
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Questions Or Comments?
Call toll free 1-800-630-8895
Monday through Friday 9 AM - 5 PM EST.
When Using This Product
- marked drowsiness may occur
- avoid alcoholic beverages
- excitability may occur, especially in children
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Keep Out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Ask A Doctor Before Use If You Have
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
Ask Your Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers.
Structured Label Content
Active Ingredient (Active ingredient (in each tablet))
Diphenhydramine HCl 25 mg
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itchy nose or throat
- temporarily relieves these symptoms of the common cold:
- runny nose
- sneezing
Purpose
Antihistamine
Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
Adults and children 12 years and over:1 or 2 caplets
Children 6 to under 12 years of age:1 caplet
Children under 6 years of age: do not use
Other Information (Other information)
- Each caplet contains:Calcium 23.52 mg
- store at controlled room temperature 20°-25°C (68°-77°F)
- read all product information before using.
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients (Inactive ingredients)
Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl alcohol, Titanium dioxide, Talc
Section 42229-5 (42229-5)
Distributed by:
Advanced Rx LLC
1942 NE 163rd St North Miami Beach,
FL 33162 U.S.A.
MADE IN THE USA
Section 51945-4 (51945-4)
NDC 80513-722-06
Compare to Benadryl ®Allergy Ultratab ®active ingredient*
ALLERGY RELIEF
DIPHENHYDRAMINE HCl 25 mg
ANTIHISTAMINE
RELIEVES:
Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat
600
MINI TABLETS
*This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl ®Allergy Ultratab ®
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
Do Not Use (do not use)
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Questions Or Comments? (Questions or comments?)
Call toll free 1-800-630-8895
Monday through Friday 9 AM - 5 PM EST.
When Using This Product (When using this product)
- marked drowsiness may occur
- avoid alcoholic beverages
- excitability may occur, especially in children
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Ask A Doctor Before Use If You Have (ask a doctor before use if you have)
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
Ask Your Doctor Or Pharmacist Before Use If You Are (ask your doctor or pharmacist before use if you are)
- taking sedatives or tranquilizers.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:26.886307 · Updated: 2026-03-14T23:09:13.832086