Label: VICKS ZZZQUIL NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER- diphenhydramine hcl, acetaminophen liquid
- NDC Code(s): 37000-598-12, 37000-598-24
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 5, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 30 mL)
- Purpose
- Use
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
• 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
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 - ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
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STOP USE
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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 354 ml bottle
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INGREDIENTS AND APPEARANCE
VICKS ZZZQUIL NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER
diphenhydramine hcl, acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-598 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYSORBATE 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color purple Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-598-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 2 NDC:37000-598-24 2 in 1 CARTON 06/01/2020 2 354 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 06/01/2020 Labeler - The Procter & Gamble Manufacturing Company (004238200) Establishment Name Address ID/FEI Business Operations Lianyungang Kangle Pharmaceutical Co., Ltd. 421319688 api manufacture(37000-598) Establishment Name Address ID/FEI Business Operations Anqiu Lu'an Pharmaceutical Co., Ltd. 544814924 api manufacture(37000-598) Establishment Name Address ID/FEI Business Operations Kongo Chemical Co., Ltd. 690908686 api manufacture(37000-598) Establishment Name Address ID/FEI Business Operations Granules India Limited 918610754 api manufacture(37000-598)