Boxed warning
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Other information store at controlled temperature 15°-30°C (59°-86°F)
Active Ingredients (in each caplet)
Acetaminophen 325 mg
Diphenhydramine HCI 25 mg
Phenylephrine HCI 5 mg
Purpose
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
Uses
Warnings Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
do not use more than directed (see overdose warning) adults and children 12 years and over
Other information
Inactive ingredients corscarmellose sodium, crospovidone, FD and C No. 1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
Questions or comments? 1-800-282-3000
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54473-184 | 54473-184-01, 54473-184-36 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 187.6 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, ORALLY DISINTEGRATING / ORAL | 4 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | SOLUTION / OPHTHALMIC | 1.8 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 350 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | SOLUTION / TOPICAL | 200 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | NA | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | POWDER, FOR SUSPENSION / ORAL | 200 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | POWDER, FOR SUSPENSION / ORAL | 11.25 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | GRANULE, FOR SUSPENSION / ORAL | 194 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | FILM / BUCCAL | 87 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | CAPSULE, COATED PELLETS / ORAL | 41.4 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | GEL / TRANSDERMAL | 20 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg |
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 |
|---|---|---|---|---|---|---|
| 994f4954-8668-606b-e053-2a95a90a5c50 | c500f07b-1a07-4afb-a98c-4a8ee9e16675 | 2019-12-09 | Boxed warning, Warnings | 994f4954-8668-606b-e053-2a95a90a5c50 c500f07b-1a07-4afb-a98c-4a8ee9e16675 |
Adverse event summaries are temporarily unavailable. Other product information remains available.