Up And Up Nighttime Sleep-aid

Up And Up Nighttime Sleep-aid
SPL v1
SPL
SPL Set ID 0d1771df-d51c-4da6-b8ca-f8aacce5b9df
Route
ORAL
Published
Effective Date 2015-01-16
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 FINAL Active Since 2015-10-20

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 if sleeplessness 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 are taking sedatives or tranquilizers or any other sleep aid

Section 53414-9

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

Directions
  • take only one dose per day (24 hours) – see Overdose warning
  • use dose cup or tablespoon

adults & children 12 yrs & over

One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient

Diphenhydramine HCl 50 mg

Other Information
  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • store at room temperature
  • protect from light. Does not meet USP <671>.
Inactive Ingredients

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Principal Display Panel

NDC 11673-730-92

Compare to active ingredient in ZzzQuil™*



nighttime

sleep-aid

diphenhydramine HCl

  •  
    non-habit forming
  •  
    alcohol free

BERRY FLAVOR



SEE WARNINGS NOT FOR TREATING COLD OR FLU

12 FL OZ (354 mL)

Failure to follow these warnings could result in serious consequences.

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®

Questions? Call 1-800-910-6874

094 01 0778 R00 ID274446

Distributed by Target Corporation Minneapolis, MN 55403

©2014 Target Brands, Inc.

Shop Target.com

When Using This Product
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
Ask A Doctor Before Use If You Have
  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

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 if sleeplessness 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 are taking sedatives or tranquilizers or any other sleep aid

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) – see Overdose warning
  • use dose cup or tablespoon

adults & children 12 yrs & over

One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Overdose Warning (Overdose warning)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (Active ingredient)

Diphenhydramine HCl 50 mg

Other Information (Other information)
  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • store at room temperature
  • protect from light. Does not meet USP <671>.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 11673-730-92

Compare to active ingredient in ZzzQuil™*



nighttime

sleep-aid

diphenhydramine HCl

  •  
    non-habit forming
  •  
    alcohol free

BERRY FLAVOR



SEE WARNINGS NOT FOR TREATING COLD OR FLU

12 FL OZ (354 mL)

Failure to follow these warnings could result in serious consequences.

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®

Questions? Call 1-800-910-6874

094 01 0778 R00 ID274446

Distributed by Target Corporation Minneapolis, MN 55403

©2014 Target Brands, Inc.

Shop Target.com

When Using This Product (When using this product)
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Advanced Ingredient Data


Raw Label Data

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