FDA Label for Medique Cold Cough Product
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 Cold Cough Product 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 caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine Hydrochloride 5 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Indications & Usage
Uses
temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ nasal congestion
■ cough
■ sinus congestion and pressure
■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
temporarily reduces fever.
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 12 caplets in 24 hours, which is the maximum daily amount
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause a severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help immediately.
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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist.
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 such as occurs with smoking, asthma, 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 dosage.
Otc - Stop Use
Stop use and ask a doctor if
■ nervousness, dizziness, or sleeplessness occur
■ pain gets worse or lasts for 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.
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. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Taking more than the recommended dose (overdose) may cause liver damage. 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 Warnings)
Adults and children: (12 years and over)
■ take 2 caplets every 4 hours
■ do not take more than 12 caplets in 24 hours
Children under 12 years: do not use this adult product in children under 12 years of age. This will provide more
than the recommended dose (overdose) and may cause liver damage.
Other Safety Information
Other information
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ tamper evident sealed packets
■ do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
Otc - Questions
Questions or comments? 1-800-634-7680
Package Label.Principal Display Panel
Medique®
Cold & Cough Product
Multi-Symptom Relief
Pull to Open
Pain Reliever/Fever Reducer • Acetaminophen 325 mg
Cough Suppressant • Dextromethorphan HBr 10 mg
Nasal Decongestant • Phenylephrine HCl 5 mg
80 Caplets
(40 x 2)
Tamper Evident Unit Dose Packets
* Please review the disclaimer below.