Indications and uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Acetaminophen PM
- Manufacturer
- Family Dollar Services Inc | LNK International, Inc.
- Effective date
- 2019-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:51:58
Label at a glance#
ProductAcetaminophen PM Extra Strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
do not take more than directed adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours children under 12 years: do not use
Storage and handling
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid high humidity see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each gelcap)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purpose
Pain reliever
Nighttime sleep-aid
Uses
temporary relief of occasional headaches and 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 are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
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.
- 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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
- adults and children 12 years and over
- take 2 gelcaps at bedtime
- do not take more than 2 gelcaps of this product in 24 hours
- children under 12 years: do not use
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive ingredients
ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide
Questions or comments?
1-800-426-9391
Principal Display Panel
FAMILY
wellness™
COMPARE TO THE ACTIVE INGREDIENTS OF
EXTRA STRENGTH TYLENOL® PM*
EXTRA STRENGTH
Acetaminophen PM
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever, Nighttime Sleep-Aid
Non-Habit Forming
40 RAPID RELEASE
GELCAPS
ACTUAL SIZE
OTC
network
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
10611 MONROE RD.
MATTHEWS, NC 28105
NOT 100% SATISFIED?
Return package and unused
product within 30 days to any
Family Dollar store for a refund
(with receipt) or exchange.
*This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Extra Strength Tylenol® PM.
50844 REV0417E55610
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 2 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 2 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | 2 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen PM Extra Strength
- Acetaminophen and Diphenhydramine HCl
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- FD&C BLUE NO. 1
- FD&C RED NO. 3
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- STEARIC ACID
- TITANIUM DIOXIDE
- FERROSOFERRIC OXIDE
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- MICROCRYSTALLINE CELLULOSE
- GELATIN, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- AMMONIA
- STARCH, CORN
- SHELLAC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-556 | 55319-556-10, 55319-556-31, 55319-556-12, 55319-556-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | GEL / TRANSDERMAL | 20 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET / ORAL | 230 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | POWDER, FOR SUSPENSION / ORAL | 11.25 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | LOTION / TOPICAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, ORALLY DISINTEGRATING / ORAL | 4 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | INSERT / VAGINAL | 54.21 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 6c29943d-bdf3-4666-9345-e3379b257dc6 | 27dc7753-d058-41fd-852b-6871e6709fd5 | 2019-12-13 | Warnings | 6c29943d-bdf3-4666-9345-e3379b257dc6 27dc7753-d058-41fd-852b-6871e6709fd5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.