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Drug Facts
TAMPER EVIDENT: DO NOT USE IF BLISTER IS OPENED OR TORN. IF DIFFICULT TO OPEN, USE SCISSORS.
MADE IN CANADA
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
Vicks Sinex Severe Capsule, Liquid Filled
FDA Label NDC 84126-382
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Sinex Severe (NDC 84126-382). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients (in each liquicap), purpose, uses, liver warning:, allergy alert:, sore throat warning:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Liquicap)
Acetaminophen 325 mg
Guaifenesin 200 mg
Purpose
Pain reliever/fever reducer
Expectorant
Uses
temporarily relieves common cold/flu symptoms:
- minor aches and pains
- headache
- fever
- sore throat
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 LiquiCaps in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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.
Directions
- take only as directed
- do not exceed 8 LiquiCaps per 24 hrs
| adults & children 12 yrs & over | 2 LiquiCaps with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
Other Information
- do not exceed 25°C
Inactive Ingredients
D&C Red No.33, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, shellac, simethicone, sorbitol, sorbitan, titanium dioxide, water
Questions?
1-800-873-8276
Principal Display Panel - 24 Liquicap Carton
VICKS®Sinex™ SEVERE
PAIN, MUCUS & CHEST CONGESTION
Acetaminophen- Pain reliever/Fever Reducer
Guaifenesin - Expectorant
- Sinus Pain & Headache
- Thins & Loosens Mucus Congestion
Medicated Relief
24 LiquiCaps™
382 (382)
* Please review the disclaimer below.
