Pain, Headache and Congestion
325 mg + 200 mg · Tablet, Film Coated
- Available without prescription
- Expectorant
- Active substance
- Acetaminophen, Guaifenesin
- Made by
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- 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 · 2026-04-28
Pain reliever/fever reducer Expectorant
- Minor aches and pains headache sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever
Adults and children 12 years and over:: take 2 caplets every 4 hours
do not take more than 12 caplets in any 24-hour period
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 common cold and flu symptoms:
- minor aches and pains headache sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever
From the official label · 2026-04-28 · 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.
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
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and over:
- take 2 caplets every 4 hours
- children under 12 years:
- do not use
Quoted from the official label, section “Dosage & Administration”.
Ask a doctor first if
liver disease 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
pain 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.
- 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.
- Do not use with any other drug containing acetaminophen (prescription or nonprescription).
- If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- Ask a doctor before use
- if you have liver disease 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.
- Stop use and
- ask a doctor
- if pain 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.
- Keep out of reach of children.
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”.
Keep away from children
- In case of 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.
Quoted from the official label, section “OTC — Keep Out of Reach of Children”.
How to store it
- each caplet contains:
- sodium 3 mg TAMPER EVIDENT:
- DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Quoted from the official label, section “Storage and Handling”.
What kind of medicine it is
Pain reliever/fever reducer Expectorant
Quoted from the official label, section “OTC — Purpose”.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Quoted from the official label, section “Inactive Ingredients”.
Questions about this product
1-800-426-9391
Quoted from the official label, section “OTC — Questions”.
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.
- Colour dyes
FD&C red #40 aluminum lake; FD&C yellow #6 aluminum lake
Some people react to dyes such as tartrazine (Yellow 5) or carmine. - 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.
Every version of this medicine (2)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 2 of 2
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
Canada1 matching products
Details
| Made by | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED |
|---|---|
| Active substance | Acetaminophen, Guaifenesin |
| Used in | Breathing, airways, allergies and cough |
| Strength | 325 mg + 200 mg |
| Form | Tablet, Film Coated |
| Route | Oral |
| Packs | 2 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK |
| NDC | 51316-809 |
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).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.