Right Remedies

Right Remedies
SPL v2
SPL
SPL Set ID de044b32-45a3-4589-814e-2f0ec869514f
Route
ORAL
Published
Effective Date 2023-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Isopropyl Alcohol Medium-chain Triglycerides Polyethylene Glycol, Unspecified Povidone, Unspecified Water Sorbitol Sorbitan

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-06

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

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

temporarily relieves these symptoms due to the common cold:

• runny nose

• sneezing

Section 42229-5

Compare to the active ingredient in Benadryl® Dye-Free Allergy*

RIGHT REMEDIES

READ AND KEEP OUTER PACKAGE FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson&Johnson Corporation, owner of the registered trademark Benadryl® Dye-Free Allergy.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

Product of United Arab Emirates

Packaged and Quality Assured in the USA

REV.00-022022

Section 50565-1

Keep out of reach of children.

Overdose warning: 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 children even if you do not notice any signs or symptoms.

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 to 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.

Packaging

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 older 1 to 2 softgels 
 children 6 to under 12 years 1 softgel 
 children under 6 years do not use 

Drug Facts

Other Information

• store at 25°C (77°F) in a dry place

• protect from light, heat and moisture

Inactive Ingredients

edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg


Structured Label Content

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

temporarily relieves these symptoms due to the common cold:

• runny nose

• sneezing

Section 42229-5 (42229-5)

Compare to the active ingredient in Benadryl® Dye-Free Allergy*

RIGHT REMEDIES

READ AND KEEP OUTER PACKAGE FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson&Johnson Corporation, owner of the registered trademark Benadryl® Dye-Free Allergy.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

Product of United Arab Emirates

Packaged and Quality Assured in the USA

REV.00-022022

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: 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 children even if you do not notice any signs or symptoms.

Purpose

Antihistamine

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 to 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.

Packaging

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 older 1 to 2 softgels 
 children 6 to under 12 years 1 softgel 
 children under 6 years do not use 

Drug Facts

Other Information (Other information)

• store at 25°C (77°F) in a dry place

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)