Drx Choice ®

Drx Choice ®
SPL v7
SPL
SPL Set ID 303d7651-9c8f-4a14-9f2c-7181fa0f003e
Route
ORAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Potassium Citrate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-17
Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor ifsleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • take only one dose per day (24 hours)
  • only use cup provided

adults & children 12yrs & over

One Dose 30 mL at bed time if needed or as directed by a doctor

Children under 12 yrs

do not use
Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each 30 mL dose contains:potassium 5 mg, sodium 10 mg
  • store at room temperature
Overdose Warning:

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

Inactive Ingredients

anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Principal Display Panel

DRx CHOICE ®

NDC 68163-730-06

Compare to in ZzzQuil® Nighttime Sleep-Aid active ingredient *

Sleep-Aid

Nighttime

Diphenhydramine HCl

Non-Habit Forming

BERRY FLAVOR

Naturally and Artificially Flavored

Not for treating Cold or Flu See Warnings

6 FL OZ (177 mL)

$1.99 AMAZING NEW VALUE!

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

When Using This Product
  • avoid alcoholic beverages
Active Ingredient (in Each 30 Ml)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Structured Label Content

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nighttime sleep-aid

Directions
  • take only one dose per day (24 hours)
  • only use cup provided

adults & children 12yrs & over

One Dose 30 mL at bed time if needed or as directed by a doctor

Children under 12 yrs

do not use
Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each 30 mL dose contains:potassium 5 mg, sodium 10 mg
  • store at room temperature
Overdose Warning: (Overdose warning:)

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

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

DRx CHOICE ®

NDC 68163-730-06

Compare to in ZzzQuil® Nighttime Sleep-Aid active ingredient *

Sleep-Aid

Nighttime

Diphenhydramine HCl

Non-Habit Forming

BERRY FLAVOR

Naturally and Artificially Flavored

Not for treating Cold or Flu See Warnings

6 FL OZ (177 mL)

$1.99 AMAZING NEW VALUE!

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

When Using This Product (When using this product)
  • avoid alcoholic beverages
Active Ingredient (in Each 30 Ml) (Active ingredient (in each 30 mL))

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:06.733646 · Updated: 2026-03-14T23:10:19.800513