FDA.reportPublic FDA data

CareOne Allergy Relief

Manufacturer
American Sales Company
Effective date
2021-11-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:27:53

Label at a glance#

ProductCareOne Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • temporarily relieves these symptoms due to the common cold: • runny nose • sneezing

Dosage and administration

• 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 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use

Storage and handling

• store at 20-25 ° C (68-77 ° F). Avoid high humidity. Protect from light. • each capsule is sealed with a Uni Band® seal which bonds the two capsule halves together. Do not use if seal is broken or missing. Do not use if blister unit is broken or torn.

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 to 2 capsules

children 6 to under 12 years

1 capsule

children under 6 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • each capsule is sealed with a Uni Band® seal which bonds the two capsule halves together. Do not use if seal is broken or missing. Do not use if blister unit is broken or torn.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, benzyl alcohol, butylparaben, D&C red no. 28, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Benadryl®

Easy To Swallow

Allergy Relief

Diphenhydramine Hydrochloride

Capsules, 25 mg

Antihistamine

Actual Size

24 CAPSULES

OUR PHARMACISTS RECOMMEND

FOR ALLERGY RELIEF OF:

Sneezing – Runny Nose

Itchy, Watery Eyes – Itchy Throat

Gluten Free

allergy relief image
allergy relief image

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-71741520-717-62

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS LACTOSE3SY5LH9PMKIACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
D&C RED NO. 28767IP0Y5NHIACT
EDETATE CALCIUM DISODIUM25IH6R4SGFIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PROPIONATE ANHYDROUS391O0PO49RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d129ca57-988e-413f-8069-81720db8910d17ec3c1a-7fee-4d84-9394-4f2f8d7ca7052021-11-12WarningsExact identifier
spl id: d129ca57-988e-413f-8069-81720db8910d
spl set id: 17ec3c1a-7fee-4d84-9394-4f2f8d7ca705

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.