FDA Label for Medique At Home Cold Relief
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Medique At Home Cold Relief Product Label
The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Active Ingredient
Active ingredients (in each tablet)
Acetaminophen 325 mg
Dextromethorphan Hydrobromide 15 mg
Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg .
Otc - Purpose
Purpose
Pain reliever/ fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Indications & Usage
Uses
■ for the temporary relief of the following cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough
■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
■ temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (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.
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.
Otc - Do Not Use
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.
■ 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
■ for more than 10 days unless directed by a doctor
Otc - Ask Doctor
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 that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema
■ cough that occurs with too much phlegm (mucus)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dose
Otc - Stop Use
Stop use and ask a doctor if
■ nervousness, dizziness, or sleeplessness occur
■ pain, nasal congestion or cough gets worse or lasts for more than 7 days
■ fever gets worse or lasts for 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.
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.
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.
Dosage & Administration
Directions
■ do not take more than directed (see overdose warning)
Adults and children12 years and older
■ take 2 tablets every 6-8 hours
■ swallow whole; do not crush, chew or dissolve
■ do not take more than 8 tablets in 24 hours
Children under 12 years
ask a doctor
Other Safety Information
Other information
■ store at room temperature 68°-77°F (20°-25°C)
■ keep this product protected from extremes of moisture, heat and light
■ Tamper Evident child resistant packets
■ do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid
Otc - Questions
Questions or comments? 1-800-634-7680
Package Label.Principal Display Panel
Medique® @ Home
Multi-Symptom Cold Relief
Acetaminophen 325 mg • Pain Reliever/ Fever Reducer
Dextromethorphan Hydrobromide 15 mg • Cough Suppressant
Guaifenesin 200 mg • Expectorant
Phenylephrine Hydrochloride 5 mg • Nasal Decongestant
Pull to Open
Child-Resistant Packets
*not actual size
50 Packets
(2 Tablets Per Packet)
* Please review the disclaimer below.