Pain Relief plus Sleep Aid

Manufacturer
Dolgencorp, LLC | Aurohealth LLC
Effective date
2020-11-20
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:05:03

Label at a glance#

ProductPain Relief plus Sleep Aid
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and administration

do not take more than directed (see overdose warning) use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. mL = milliliter adults and children 12 years and over take 30 mL at bedtime do not take more than 30 mL in 24 hours children under 12 years do not use

Storage and handling

each 15 mL contains: sodium 9 mg store between 20-25°C (68-77°F). Do not refrigerate. don't use if shrink band is missing or broken see back label for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 15 mL)

Acetaminophen USP 500 mg

Diphenhydramine HCl USP 25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever
Nighttime Sleep Aid

Uses

INDICATIONS & USAGE SECTION

Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
  • for 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

OTC - ASK DOCTOR SECTION

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers or any other sleep aid

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
adults and children 12 years and over
  • take 30 mL at bedtime
  • do not take more than 30 mL in 24 hours
children under 12 years
do not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 9 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
  • don't use if shrink band is missing or broken
  • see back label for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C Blue no.1, FD&C Green no. 3, flavors, high fructose corn syrup, menthol, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, and sucralose

Questions or Comments?

OTC - QUESTIONS SECTION

1-888-309-9030

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
100% SATISFACTION GUARANTEED!
(888) 309-9030

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DGTM| health

Pain Relief +
Sleep Aid
 ACETAMINOPHEN - Pain Reliever
Diphenhydramine HCl - Nighttime Sleep Aid
 Berry Flavor

Alcohol free

8 FL OZ (237 mL)

DO NOT USE IF PRINTED SHIRNKBAND IS MISSING OR BROKEN.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-99655910-996-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d6186335-22ef-4289-acea-21024cde844256535f0c-d5f3-483b-a9a5-dd0efcaa78662020-11-20WarningsExact identifier
spl id: d6186335-22ef-4289-acea-21024cde8442
spl set id: 56535f0c-d5f3-483b-a9a5-dd0efcaa7866

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.