NIGHTTIME PAIN RELIEVER PLUS SLEEP AID- acetaminophen, diphenhydramine hcl solution

Nighttime Pain Reliever plus Sleep Aid by

Drug Labeling and Warnings

Nighttime Pain Reliever plus Sleep Aid by is a Otc medication manufactured, distributed, or labeled by WALMART INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 1,000 mg
Diphenhydramine HCl 50 mg

Purpose

Pain reliever
Nighttime sleep-aid

Use

for the temporary relief of occasional minor aches and pains with accompanying sleeplessness

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours
  
• 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.
  
• with any other product containing diphenhydramine, even one used on skin
  
• in children under 12 years of age
  
• if you have ever had an allergic reaction to this product or any of its ingredients
  

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
  
• taking sedatives or tranquilizers
  

When using this product

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

Stop use and ask a doctor if

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

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Directions

• do not take more than directed
• mL = milliliter
• only use the dose cup provided
• adults and children 12 years and over: 30 mL at bedtime
• take only one dose per day (24 hours)
• children under 12 years: do not use

Other information

• each 30 mL contains: sodium 12 mg
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package
  

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-888-287-1915

Principal display panel

equate™

NDC: 79903-099-02

Compare to
VICKS® ZzzQuil®
NIGHT PAIN
active
ingredients*

Nighttime
Pain Reliever +
Sleep-Aid

Acetaminophen
Diphenhydramine HCl

Pain Reliever/Nighttime Sleep-Aid

Maximum Strength
   pain relief
Non-habit forming

For Ages 12+

Midnight-Berry
Flavor

12 FL OZ (355 mL)

TAMPER EVIDENT: DO NOT USE IF
PRINTED NECK WRAP IS BROKEN
OR MISSING

Satisfaction Guaranteed- Or we'll replace it or give you your money back. For questions
or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by The Procter &
Gamble Company, owner of the registered trademark VICKS®
ZzzQuil® NIGHT PAIN.                         50844          REV0523A07402

Equate 44-074

INGREDIENTS AND APPEARANCE

NIGHTTIME PAIN RELIEVER PLUS SLEEP AID 
acetaminophen, diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-099
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	purple (Dark)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79903-099-02	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/12/2022

Labeler - WALMART INC. (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(79903-099) , pack(79903-099)