Allergy Relief

Set ID
18df23eb-1f3d-4936-b9bd-e5d71d100bcb
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:41:32

Key Label Information

Active Ingredients And Purpose

Active Ingredient

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Warnings

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 • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

If pregnant or breast-feeding,

ask a health professional before use.

Directions And Dosage

Directions

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults & children 12 years & over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use this product in children under 6 years of age

Other Label Information

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 27 Aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-888-333-9792

Pouch Label

Compare to the active ingredient in: Benadryl® Allergy* Diphenhydramine HCl 25 mg** Relieves: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat **May cause drowsiness

Products

NDC Codes

Ingredients

NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DICALCIUM CITRATELGH2B6RC26IACT
D&C RED NO. 272LRS185U6KIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Complete SPL Sections

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

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 • 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

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 do not take more than 6 doses in 24 hours adults & children 12 years & over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use this product in children under 6 years of age

Other information

OTHER SAFETY INFORMATION

• each tablet contains: calcium 24 mg • store between 15–30°C (59–86°F) • protect from moisture and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 27 Aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

CABINET HEALTH P.B.C.

Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in: Benadryl® Allergy* Diphenhydramine HCl 25 mg** Relieves: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat **May cause drowsiness

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/18df23eb-1f3d-4936-b9bd-e5d71d100bcb/28de35d0-7e3d-dfb1-e063-6294a90a1e56.xml
XML SHA-256
06164078a0df8376c9d1d557a8bf9713fbf11908e01fd156d4ff7c5143bda614
XML bytes
23342

Legacy File Index

FolderFileDate
otc28de35d0-7e3d-dfb1-e063-6294a90a1e56.xml2024-12-11
otc0bde3e63-1c4d-3d9c-e063-6394a90ac09c.xml2023-12-07
otcAllergy Pouch Back.jpg2022-11-17
otcAllergy Pouch Front.jpg2022-11-17
otced99a540-7e70-3ea3-e053-2995a90a611e.xml2022-11-17