Cvs Nighttime Sleep-aid Pain Reliever

Cvs Nighttime Sleep-aid Pain Reliever
SPL v6
SPL
SPL Set ID 333e170e-52cd-4218-8d15-0bf3c5c75cb9
Route
ORAL
Published
Effective Date 2021-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (1000 mg) Diphenhydramine (50 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Potassium Citrate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-12

Description

Drug Facts

Purpose

Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Pain reliever

Nighttime sleep-aid

Description

Drug Facts

Uses
  • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

These could be signs of a serious condition.

Section 50567-7

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
Section 53414-9

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4 doses (30 mL each) in 24 hrs., which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away

Directions
  • take only one dose (30 mL) per day (24 hours)
  • Only use dose cup provided

adults & children 12 yrs & over

30 mL at bedtime

children under 12 yrs

do not use

Other Information
  • each 30 mL contains:sodium 10 mg
  • store at room temperature
  • very low sodium
Inactive Ingredients

citric acid, flavors, FD&C Blue No. 1, FD&C Red No. 40, glycerin, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose.

Questions Or Comments?

1-866-467-2748

Active Ingredients (in Each 30 Ml)

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Principal Display Panel 354 Ml Bottle

Compare to the active ingredient in Vicks® ZzzQuil™ Night Pain Sleep-Aid*

NDC# 69842-448-12



Nighttime Sleep-Aid

Pain Reliever



Diphenhydramine HCl

Acetaminophen

  • Fall Asleep Fast
  • Max Strength Pain Reliever
  • Non-Habit Forming

Berry Flavor

Naturally and Artificially Flavored

No Added Alcohol

12 FL. OZ. (354 ml)

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

Distributed by:


Structured Label Content

Uses
  • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Section 50570-1 (50570-1)

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
Section 53414-9 (53414-9)

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

Purpose

Pain reliever

Nighttime sleep-aid

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4 doses (30 mL each) in 24 hrs., which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away

Directions
  • take only one dose (30 mL) per day (24 hours)
  • Only use dose cup provided

adults & children 12 yrs & over

30 mL at bedtime

children under 12 yrs

do not use

Other Information (Other information)
  • each 30 mL contains:sodium 10 mg
  • store at room temperature
  • very low sodium
Inactive Ingredients (Inactive ingredients)

citric acid, flavors, FD&C Blue No. 1, FD&C Red No. 40, glycerin, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Principal Display Panel 354 Ml Bottle (PRINCIPAL DISPLAY PANEL - 354 ml bottle)

Compare to the active ingredient in Vicks® ZzzQuil™ Night Pain Sleep-Aid*

NDC# 69842-448-12



Nighttime Sleep-Aid

Pain Reliever



Diphenhydramine HCl

Acetaminophen

  • Fall Asleep Fast
  • Max Strength Pain Reliever
  • Non-Habit Forming

Berry Flavor

Naturally and Artificially Flavored

No Added Alcohol

12 FL. OZ. (354 ml)

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

Distributed by:


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