FDA.reportPublic FDA data

Acedif PLUS

Manufacturer
Plus Distributors LLC
Effective date
2019-02-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:30:38

Label at a glance#

ProductAcedif PLUS
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Diphenhydramine HCl 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 accompanying sleeplessness

Warnings

WARNINGS SECTION

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

  • more than 4000 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 incluse:

  • 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 other products 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

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

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 care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 between 15- 30o C (59- 86o F)
  • avoid high humidity and excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax*, croscarmellose sodium*, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, polyvinyl alcohol*, povidone K30, pregelatinized starch, purified water*, silicon dioxide*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide

*contains one or more of these ingredients

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength 

Pain Reliever PM

pain reliever/nighttime sleep-aid

Acetaminophen 500 mg

diphenhydramine HCl 25 mg

non-habit forming

for ages 12 years and over

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acedif PLUS
Acedif PLUS

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72828-44772828-447-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TALC7SEV7J4R1UIACT
ALUMINUM OXIDELMI26O6933IACT
CARNAUBA WAXR12CBM0EIZIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT

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
3513caae-b107-4c7c-aeb8-38eb41b720067db51ee2-b8b6-4f79-9bb7-96f468c4fff22020-12-14WarningsExact identifier
spl set id: 7db51ee2-b8b6-4f79-9bb7-96f468c4fff2

Reported adverse events (FAERS/openFDA)#

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