EQUATE PAIN RELIEF PM- acetaminophen, diphenhydramine hydrochloride solution

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 1000 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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or

followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.
• in children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• 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
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• 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

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

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
• redness or swelling is present
• 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (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.

Directions

• take only one dose (30 mL) per day (24 hours)
• only use the dose cup provided
• take only as directed – see Overdose warning

• adults & children 12 yrs & over:

  30 mL at bedtime

• children under 12 yrs:

  do not use

Other information

• each 30 mL contains: sodium 25 mg
• store at 20-25°C (68-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, benzyl alcohol, FD&C blue #1, FD&C red #40, flavor, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions?

1-888-287-1915

Package/Label Principal Display Panel

equate™

Compare to Vicks® PainQuil® PM active ingredients

MAXIMUM STRENGTH

Pain Relief PM

Acetaminophen

Diphenhydramine HCl

Pain Reliever/Nighttime Sleep-Aid

Starts Working Fast

Relief of:

Aches

Pains

Headache

Sore throat + Occasional sleeplessness

Adults

Midnight Cherry Flavor

12 FL OZ (355 mL)

10% ALCOHOL

INGREDIENTS AND APPEARANCE

EQUATE PAIN RELIEF PM 
acetaminophen, diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-421
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
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79903-421-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	04/29/2026

Labeler - WALMART INC. (051957769)