Indications and uses
temporarily relieves common cold and flu symptoms: nasal congestion cough due to minor throat and bronchial irriation sore throat headache minor aches and pains fever
temporarily relieves common cold and flu symptoms: nasal congestion cough due to minor throat and bronchial irriation sore throat headache minor aches and pains fever
• take only as directed (see Warnings) • do not exceed 4 doses per 24 hours • Adults and children 12 years of age and older: take 2 softgels with water every 4 hours • Children 4 to under 12 years: ask a doctor • Children under 4 years: do not use
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
temporarily relieves common cold and flu symptoms:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you
take more than 4 doses in 24 hours, which is the maximum daily amount
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.
Store throat warning: If sore throat is severe, persists for morethan 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
• liver disease • heart disease • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland. • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema
taking the blood thinning drug warfarin
do not exceed recommended dosage
• you get nervous, dizzy or sleepless • symptoms get worse or lasts more than 5 days (children) or 7 days (adults) • fever gets worse or lasts more than 3 days • redness or swelling is present new symptoms occur • cough come back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
ask a health professional before use.
In case of accidental overdose, contact a doctor or Poison Control Center immediately.
• take only as directed (see Warnings)
• do not exceed 4 doses per 24 hours
• Adults and children 12 years of age and older: take 2 softgels with water every 4 hours
• Children 4 to under 12 years: ask a doctor
• Children under 4 years: do not use
Polyethylene glycol 600, Polyethylene glycol 400, Purified water, Povidone, Propylene glycol, Gelatin, Concentrated glycerin, D-sorbitol, Ethyl vanillin, FD&C Blue # 1, FD&C Red # 40
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 8936027006713 | GTIN-13: 8936027006713 EAN-13: 8936027006713 GTIN storage (14 digits): 08936027006713 | Label.jpg |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71038-101 | 71038-101-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| GELATIN | 2G86QN327L | IACT |
| SORBITOL | 506T60A25R | IACT |
| ETHYL VANILLIN | YC9ST449YJ | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
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 |
|---|---|---|---|---|---|---|
| c4414da8-e7a0-19ec-e053-2a95a90affab | bb2c505a-43a3-4aaa-873f-96a21f5f98d0 | 2021-06-08 | Warnings | bb2c505a-43a3-4aaa-873f-96a21f5f98d0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.