Indications and uses
temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
Adults and children 12 years of age and over Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. Children under 12 years of age Do not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems
store between20-25 C (68-77 F) do not use if pouch is torn or open
Drug Facts
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Acetaminophen 500 mg | Pain reliever |
| Diphenhydramine HCl 25 mg | Nighttime sleep aid |
temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
This product contains acetaminophen. Severe liver damage may occur if you take
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.
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.
| Adults and children 12 years of age and over | Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. |
| Children under 12 years of age | Do not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems |
croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.
Call 1-800-570-8650 (M-F 9am to 5pm PST)
Product manufactured for:
Eagle Distributors,Inc.
Los Angeles, CA 90011
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68737-224-08 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d1db-f6ea-e053-dbdaa90aa703 | PM Get Relief |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68737-224-08 | PM Get Relief | 50 in 1 BOX | TABLET | 50 | 1 | |
| 68737-224-08 | PM Get Relief | 2 in 1 POUCH | TABLET | 2 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Diphenhydramine Hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FD&C blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68737-224 | 68737-224-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| Diphenhydramine Hydrochloride | TC2D6JAD40 | ACTIB |
| croscarmellose sodium | M28OL1HH48 | IACT |
| FD&C blue no. 1 | H3R47K3TBD | IACT |
| hypromelloses | 3NXW29V3WO | IACT |
| cellulose, microcrystalline | OP1R32D61U | IACT |
| polyethylene glycols | 3WJQ0SDW1A | IACT |
| povidone | FZ989GH94E | IACT |
| stearic acid | 4ELV7Z65AP | IACT |
| titanium dioxide | 15FIX9V2JP | IACT |
| polyvinyl alcohol | 532B59J990 | IACT |
| silicon dioxide | ETJ7Z6XBU4 | IACT |
| talc | 7SEV7J4R1U | IACT |
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 |
|---|---|---|---|---|---|---|
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| povidone | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| talc | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| povidone | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| povidone | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| povidone | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE / ORAL | 72 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | POWDER, FOR SUSPENSION / ORAL | 11.25 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| talc | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| povidone | POVIDONE | FZ989GH94E | TABLET, EXTENDED RELEASE / ORAL | 101 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | TABLET, EXTENDED RELEASE / ORAL | 96 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, EXTENDED RELEASE / ORAL | 392 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | INJECTION / INTRAMUSCULAR | 1 %w/v | ||
| povidone | POVIDONE | FZ989GH94E | SUSPENSION / AURICULAR (OTIC) | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| talc | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| povidone | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| povidone | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| povidone | POVIDONE | FZ989GH94E | TABLET, DELAYED RELEASE / ORAL | 53 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 8bf7e7ac-aa38-4ba5-8c4f-55d15e27f7b0 | 05703022-d12c-4c1b-b995-b772ffa3e861 | 2012-06-11 | Warnings | 8bf7e7ac-aa38-4ba5-8c4f-55d15e27f7b0 05703022-d12c-4c1b-b995-b772ffa3e861 |
Adverse event summaries are temporarily unavailable. Other product information remains available.