FDA Label for Medi-first Plus Cough Cold
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
Medi-first Plus Cough Cold 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 Hydrobromide 10 mg
Guaifenesin 100 mg
Phenylephrine Hydrochloride 5 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Indications & Usage
Uses
Temporarily relieves these symptoms due to the common cold:
- headache
- nasal congestion
- cough
- minor aches and pains
- sore throat
- sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
Temporarily reduces fever.
Warnings
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
- blisters
- rash
- skin reddening
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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 have ever had an allergic reaction to this product or any of its ingredients
- 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.
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema
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, cough, or nasal congestion 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.
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 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.
Dosage & Administration
Directions
- do not take more than directed
- take 2 caplets every 4 hours
- not to take more than 10 caplets in 24 hours
Adults and children: (12 years and over)
Children under 12 years: ask a doctor
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
corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Otc - Questions
Questions or comments? 1-800-634-7680
Package Label.Principal Display Panel
Medi-First®
Cough & Cold Relief
✓ Aches, Fever • Acetaminophen 325 mg
✓ Coughs • Dextromethorphan HBr 10 mg
✓ Chest Congestion • Guaifenesin 100 mg
✓ Nasal Congestion • Phenylephrine HCl 5 mg
Pull to Open
Multi-Symptom Relief
This Package is for Households Without Young Children.
80 Caplets (40 x 2)
Tamper evident Unit Dose Packets
Medi-First® Plus
Cough & Cold Relief
Aches, Fever • Acetaminophen 325 mg
Coughs • Dextromethorphan HBr 10 mg
Chest Congestion • Guaifenesin 100 mg
Nasal Congestion • Phenylephrine HCl 5 mg
This Package is for Households Without Young Children.
Pull To Open
80 Caplets
(40 x 2's)
Relieves pain, fever, cough, and sinus pressure
Tamper Evident Unit Dose Packets
Medique®
Decorel Forte
✓ Aches, Fever • Acetaminophen 325 mg
✓ Coughs • Dextromethorphan HBr 10 mg
✓ Chest Congestion • Guaifenesin 100 mg
✓ Nasal Congestion • Phenylephrine HCl 5 mg
Severe Cold & Cough Relief
This Package is for Households Without Young Children.
Pull to Open
80 Caplets
(40 x 2)
Tamper Evident Unit Dose Packets
* Please review the disclaimer below.