OTC - ACTIVE INGREDIENT SECTION
Active ingredeints in each softgel
ACETAMINOPHEN 325 mg
Dextromethorphan Hydrobromide 10 mg
Doxylamine Succinate 6.25 mg
Phenylephrine HCl 5 mg
Active ingredeints in each softgel
ACETAMINOPHEN 325 mg
Dextromethorphan Hydrobromide 10 mg
Doxylamine Succinate 6.25 mg
Phenylephrine HCl 5 mg
Inactive ingredients: FD&C Blue #1,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, , sorbitol sorbitan solution, titanium dioxide
PURPOSE
Pain Reliever-Fever Reducer
Cough Suppressant
Antihistamine
Nasal Decongestant
INDICATIONS & USAGE
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache · cough
· sore throat · nasal and sinus congestion
· temporarily reduces fever
Directions
· do not take more than the recommended dose
· adults and children 12 years and over: take 2 capsules with water
every 4 hours. Do not exceed 10 capsules in 24 hours or as
directed by a doctor.
· children under 12 years: do not use
Keep out of reach of children. 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.
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 aloholic drinks every day while using this product
l Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
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.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11673-946-08 | 2025-02-15 | C162847 | 48780-1 | 2cef2736-5d36-d83d-e063-dadaa90ab31f | 633T TARGET COLD AND FLU RELIEF(ALKA) 11673-946 8 count |
| 11673-946-08 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5d36-d83d-e063-dadaa90ab31f | 633T TARGET COLD AND FLU RELIEF(ALKA) 11673-946 8 count |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11673-946 | 11673-946-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SHELLAC | 46N107B71O | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| GELATIN | 2G86QN327L | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| POVIDONE | FZ989GH94E | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
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 |
|---|---|---|---|---|---|---|
| 2e2a572b-dcce-5683-e063-6394a90ac18e | 9e01ce3b-b6a9-145b-e053-2a95a90ad892 | 2025-02-15 | Warnings | 9e01ce3b-b6a9-145b-e053-2a95a90ad892 |
Adverse event summaries are temporarily unavailable. Other product information remains available.