OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg
Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg
colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow#6, magnesium staerate, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, stearic acid, talc
| adults & children 12 years of age & over | 2 caplets with water every 4 hours |
| children 4 to 12 years of age | ask a doctor |
| children under 4 years of age | do not use |
*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
if a skin 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
Do not use
Ask a doctor before use if you have
Ask a doctor or a 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: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of reach of children
Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Pain reliever / fever reducer, cough suppressant, expectorant, nasal decongestant
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70692-108-41 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6505-a426-e053-dadaa90af4c2 | Cold & Flu - Gripa (Acetaminophen 325mg; Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70692-108-41 | Acetaminophen 500mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg | 4 in 1 PACKAGE | TABLET | 4 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70692-108 | ACETAMINOPHEN 500MG, DEXTROMETHORPHAN HBR 10MG, GUAIFENESIN 200MG, PHENYLEPHRINE HCL 5MG TABLET [STRIVE PHARMACEUTICALS INC] | 2 | Legacy NDC, 1 package rows | 20201117_9239bf18-0e2b-20d5-e053-2a95a90addc8.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70692-108 | 70692-108-41 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| b43d2d83-1d7c-6187-e053-2a95a90a7bc2 | 9239bf18-0e2b-20d5-e053-2a95a90addc8 | 2020-11-16 | Warnings | b43d2d83-1d7c-6187-e053-2a95a90a7bc2 9239bf18-0e2b-20d5-e053-2a95a90addc8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.