Label: RITEAID NIGHTTIME SLEEP AID- diphenhydramine hydrochloride and acetaminophen liquid
- NDC Code(s): 11822-8791-1
- Packager: RITE AID CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 30 mL)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
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- adult takes more than 4 doses (30 mL each) in 24 hrs., which is the maximum daily amount for this product
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- taken with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy Alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- for children under 12 years of age
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- with any other product containing diphenhydramine, even one used on skin.
Ask a doctor before use if you have
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- liver disease
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- a breathing problem such as emphysema or chronic bronchitis
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- glaucoma
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- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
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- taking the blood thinning drug warfarin
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- taking sedatives or tranquilizers
When using this product
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- avoid alcoholic beverages
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- drowsiness will occur
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- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- new symptoms occur
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- 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - 354 ml bottle
Compare to the active ingredient in Vicks® ZzzQuil™ Night Pain Sleep-Aid*
NDC# 11822-8791-1
Nighttime Sleep-AidPain Reliever
Diphenhydramine HClAcetaminophen
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- Fall Asleep Fast
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- Max Strength Pain Reliever
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- 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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INGREDIENTS AND APPEARANCE
RITEAID NIGHTTIME SLEEP AID
diphenhydramine hydrochloride and acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-8791 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg in 30 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-8791-1 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 06/01/2021 Labeler - RITE AID CORPORATION (014578892)