Indications and uses
temporarily relieves these common cold/flu symptoms: • minor aches and pains • headache • sore throat • fever • nasal congestion • cough due to minor throat and bronchial irritation
temporarily relieves these common cold/flu symptoms: • minor aches and pains • headache • sore throat • fever • nasal congestion • cough due to minor throat and bronchial irritation
• take only as recommended (see overdose warning) • use dosage cup or tablespoon (TBSP) • do not exceed 5 doses (children) or 6 doses (adults) per 24 hours Age Dose adults and children 12 years and older.........2 tablespoons (30 mL) every 4 hours children 6 years to under 12 years................ 1 tablespoon (15 mL) every 4 hours children 4 years to under 6 years...................do not use unless directed by a...
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg
Acetaminophen..................................Pain reliever/fever reducer
Dextromethorphan HBr.....................Cough suppressant
Phenylephrine HCI............................Nasal decongestant
temporarily relieves these common cold/flu symptoms:
• minor aches and pains • headache • sore throat • fever
• nasal congestion • cough due to minor throat and bronchial irritation
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 6 doses (12 tablespoonfuls or 180 mL) in 24 hours for adults
• more than 5 doses (5 tablespoonfuls or 75 mL) in 24 hours for
children 6-12 years old
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while using this product
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.
• if you are on a sodium-restricted diet
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI)
(certain drugs for depression, psychiatric or emotional conditions, or Parkinson's
disease), or for two weeks after stopping the MAOI drug. If you do not know if your
prescription drug contains an MAOI, ask a doctor or pharmacist before taking this
product. • with any other drug containing acetaminophen (prescription or
non-prescription). If you are not sure whether a drug contains acetaminophen, ask a
doctor or pharmacist.
• liver disease • heart disease • thyroid disease • diabetes • high blood pressure
• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• cough accompanied by excessive phlegm (mucus)
• trouble urinating due to enlarged prostate gland
taking the blood thinning drug warfarin
• avoid alcoholic drinks
• do not use more than directed (see overdose warning)
• redness or swelling is present • new symptoms occur
• you get nervous, dizzy or sleepless
• pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• fever gets worse or lasts more than 3 days
• cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
ask a health professional before use.
Overdose Warning: Taking more than the recommended dose (overdose) could cause
serious health problems, including liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Quick medical
attention is critical for adults as well as for children even if you do not notice any signs
or symptoms.
• take only as recommended (see overdose warning)
• use dosage cup or tablespoon (TBSP)
• do not exceed 5 doses (children) or 6 doses (adults) per 24 hours
Age Dose
adults and children 12 years and older.........2 tablespoons (30 mL) every 4 hours
children 6 years to under 12 years................ 1 tablespoon (15 mL) every 4 hours
children 4 years to under 6 years...................do not use unless directed by a doctor
children under 4 years.....................................do not use
• When using Day Time and Night Time products, carefully read each
label to ensure correct dosing.
• sodium content per tablespoon: 71 mg
• store at controlled room temperature
citric acid, flavor, glycerin, polyethylene glycol,
propylene glycol, purified water, saccharin sodium, sodium citrate,
sucrose, yellow 6
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Polyethylene Glycol 300 | INACTIVE INGREDIENT | 5655G9Y8AQ | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Saccharin Sodium Anhydrous | INACTIVE INGREDIENT | I4807BK602 | 1 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11822-3416 | 11822-3416-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM ANHYDROUS | I4807BK602 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCROSE | C151H8M554 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | 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 |
|---|---|---|---|---|---|---|
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, DELAYED RELEASE / ORAL | 2 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| Polyethylene Glycol 300 | POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 44.22 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAOCULAR | 1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / RESPIRATORY (INHALATION) | 0.13 %w/w | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / NASAL | 2.8 mg/1ml | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRATHECAL | ADJ PH | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / TOPICAL | 4 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / RESPIRATORY (INHALATION) | 0.03 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | EMULSION / TOPICAL | 0.11 %w/w | ||
| Saccharin Sodium Anhydrous | SACCHARIN SODIUM ANHYDROUS | I4807BK602 | INJECTION / INTRAMUSCULAR | 0.09 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| Saccharin Sodium Anhydrous | SACCHARIN SODIUM ANHYDROUS | I4807BK602 | SOLUTION / RECTAL | 0.67 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EFFERVESCENT / ORAL | 460 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Saccharin Sodium Anhydrous | SACCHARIN SODIUM ANHYDROUS | I4807BK602 | INJECTION / INTRAVENOUS | 0.09 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / IONTOPHORESIS | 0.2 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, DELAYED RELEASE / ORAL | 0.02 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE, EXTENDED RELEASE / ORAL | 101 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / ORAL | 914 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CONCENTRATE / ORAL | 0.03 mg/5ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml |
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 |
|---|---|---|---|---|---|---|
| 2f10aec5-a077-4443-8dc6-53b76f031e0c | dbf1a3bf-524c-4079-91dc-edef40c0d3ae | 2019-09-27 | Warnings | 2f10aec5-a077-4443-8dc6-53b76f031e0c dbf1a3bf-524c-4079-91dc-edef40c0d3ae |
Adverse event summaries are temporarily unavailable. Other product information remains available.