Sinus Congestion and Pain Severe
200 mg + 5 mg + 325 mg · Tablet, Coated
- Available without prescription
- Expectorant
- Active substance
- Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
- Made by
- TopCare
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2024-12-03
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
- Sinus congestion and pressure headache nasal congestion minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
Adults and children 12 years and over: take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve
do not take more than 10 caplets in 24 hours
Full directions ↓With any other drug containing acetaminophen (prescription or nonprescription).
All warnings ↓- Sold without a prescription
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- sinus congestion and pressure headache nasal congestion minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
From the official label · 2024-12-03 · DailyMed
Do not take it if
- with any other drug containing acetaminophen (prescription or nonprescription).
- If you are not sure whether a drug contains acetaminophen,
- ask a doctor or pharmacist.
- 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 2 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Quoted from the official label, section “OTC — Do Not Use”.
How to take it
These directions are for this exact strength and form. Another one is different.
- do not take more than directed (see overdose warning )
- adults and children 12 years and over
- take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- children under 12 years
- ask a doctor
Quoted from the official label, section “Dosage & Administration”.
Ask a doctor first if
liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)
Quoted from the official label, section “OTC — Ask Doctor”.
Ask a pharmacist first if
you are taking the blood thinning drug warfarin
Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.
Stop and get help if
nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.
Quoted from the official label, section “OTC — Stop Use”.
Other warnings
- Liver warning This product contains acetaminophen.
- The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours.
- 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.
- Do not use with any other drug containing acetaminophen (prescription or nonprescription).
- Ask a doctor before use
- if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)
- Ask a doctor or pharmacist before use
- if you are taking the blood thinning drug warfarin
- When using this product
- do not exceed recommended dosage
- Stop use and
- ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.
- Keep out of reach of children.
- Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
- Quick medical attention is critical for
- adults as well as for children even
- if you do not notice any signs or symptoms.
- do not exceed recommended dosage
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
How to store it
store between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information
Quoted from the official label, section “Storage and Handling”.
What kind of medicine it is
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
Quoted from the official label, section “OTC — Purpose”.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
Quoted from the official label, section “Inactive Ingredients”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Titanium dioxide
titanium dioxide
A whitening agent no longer allowed in food in the EU (E171).
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Details
| Made by | TopCare |
|---|---|
| Active substance | Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride |
| Used in | Breathing, airways, allergies and cough |
| Strength | 200 mg + 5 mg + 325 mg |
| Form | Tablet, Coated |
| Route | Oral |
| Packs | 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK |
| NDC | 36800-505 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet, Coated1 products
- 200 mg + 5 mg + 325 mg
- Tablet, Film Coated1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.
See every product with Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride