Active Ingredients And Purpose
Active ingredients (in each caplet)
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
topcare day time cold and flu
- Manufacturer
- Topco Associates LLC
- Effective date
- 2024-11-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:35:19
Key Label Information#
Uses
Uses
• temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
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 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. 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.
Directions And Dosage
Directions
• take only as directed - see overdose warning • do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Other Label Information
Other information
• each caplet contains: sodium 3 mg • store at 20-25°C (68-77°F)
Inactive ingredients
croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Questions or comments?
1-888-423-0139
Package/Label Principal Display Panel
TopCare ® health COMPARE TO VICKS ® DAYQUIL ® SEVERE+ VAPOCOOL ™ ACTIVE INGREDIENTS VAPOR ICE ® DayTime Cold & Flu SEVERE PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr EXPECTORANT – GUAIFENESIN NASAL DECONGESTANT – PHENYLEPHRINE HCl • Minor Aches & Pains, Fever • Nasal Congestion & Sinus Pressure • Cough • Chest Congestion Maximum Strength Non-Drowsy 24 CAPLETS actual size
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 5 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 5 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 5 |
DailyMed Pharmacologic Classes#
| 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-581-62 | topcare day time cold and flu | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 5 | |
| 36800-581-62 | topcare day time cold and flu | 12 in 1 CARTON | TABLET, FILM COATED | 12 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-581 | TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241109_1a8e2e03-e11b-4da1-945b-e2caadea7243.zip |
Products#
- topcare day time cold and flu
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- DEXTROMETHORPHAN
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-581 | 36800-581-62 |
Ingredients#
Complete SPL Sections#
Active ingredients (in each caplet)
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Uses
• temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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 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. 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.
Directions
• take only as directed - see overdose warning • do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Other information
• each caplet contains: sodium 3 mg • store at 20-25°C (68-77°F)
Inactive ingredients
croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Questions or comments?
1-888-423-0139
Package/Label Principal Display Panel
TopCare ® health COMPARE TO VICKS ® DAYQUIL ® SEVERE+ VAPOCOOL ™ ACTIVE INGREDIENTS VAPOR ICE ® DayTime Cold & Flu SEVERE PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr EXPECTORANT – GUAIFENESIN NASAL DECONGESTANT – PHENYLEPHRINE HCl • Minor Aches & Pains, Fever • Nasal Congestion & Sinus Pressure • Cough • Chest Congestion Maximum Strength Non-Drowsy 24 CAPLETS actual size