FDA.reportPublic FDA data

Acetaminophen, Diphenhydramine Hydrochloride

Manufacturer
REMEDYREPACK INC.
Effective date
2021-10-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:34:15

Label at a glance#

ProductAcetaminophen, Diphenhydramine Hydrochloride
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 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) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

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.

OTC - DO NOT USE SECTION

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

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.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
  • children under 12 years: do not use

Other information

OTHER SAFETY INFORMATION

store at room temperature

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

(800) 231-4670

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Acetaminophen, Diphenhydramine Hydrochloride

GENERIC: Acetaminophen, Diphenhydramine Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-2740-0

COLOR: blue

SHAPE: OVAL

SCORE: No score

SIZE: 17 mm

IMPRINT: CPC752

PACKAGING: 50 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 1
  • ACETAMINOPHEN 500mg in 1

INACTIVE INGREDIENT(S):

  • TALC
  • TITANIUM DIOXIDE
  • STEARIC ACID
  • LIGHT MINERAL OIL
  • D&C YELLOW NO. 10
  • MAGNESIUM STEARATE
  • TRIACETIN
  • FD&C BLUE NO. 1
  • CROSCARMELLOSE SODIUM
  • POVIDONE K30
  • STARCH, CORN
  • SILICON DIOXIDE
  • HYPROMELLOSES
  • SODIUM STARCH GLYCOLATE TYPE A POTATO

Remedy_LabelRemedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2740-02023-10-16C16284748780-1f386c649-9f75-0266-e053-dadaa90a7c1a0752-Cardinal
70518-2740-02023-01-30C16284748780-1f386c649-9f75-0266-e053-dadaa90a7c1a0752-Cardinal

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0411-1EA - Each70000-041115fd30a1-2ad7-436f-be92-9b92e7c98b6712019-08-06
70000-0411-2EA - Each70000-041138d72d75-ca00-495d-ba2f-f47c8f99fd2112019-08-06
70000-0411-3EA - Each70000-041188c57048-0046-45d5-8256-8d2dfb5493ff12019-08-06

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-274070518-2740-0
70000-0411

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STEARIC ACID4ELV7Z65APIACT
LIGHT MINERAL OILN6K5787QVPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
MAGNESIUM STEARATE70097M6I30IACT
TRIACETINXHX3C3X673IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSES3NXW29V3WOIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen, Diphenhydramine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.7be4d67e-1af9-f059-e053-2991aa0a382e2026-02-26WarningsExact identifier
ndc (product): 70000-0411
07d70030-ece4-e1c3-e063-6394a90a3d4743fba3c6-412e-41bb-a627-0a48e5261a9e2023-10-16WarningsExact identifier
spl set id: 43fba3c6-412e-41bb-a627-0a48e5261a9e

Reported adverse events (FAERS/openFDA)#

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