FDA Label for Physicians Care Non-drowsy Cold And Cough
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING THE BLOOD THINNING DRUG WARFARIN.
- WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSAGE.
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS
- PHYSICIANS CARE COLD & COUGH
Physicians Care Non-drowsy Cold And Cough Product Label
The following document was submitted to the FDA by the labeler of this product Acme United. 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.
Drug Facts
Drug Facts
Active Ingredient
Active ingredient (in each caplet)
Acetaminophen 325 mg
Dextromethorphan Hydrobromide 10 mg
Guaifenesin 100 mg
Phenylephrine Hydrochloride 5 mg
Purpose
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
Uses
Temporarily relieves these cold symptoms
- cough
- sore throat
- minor aches and pains
- headache
- nasal congestion
- 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
- skin reddening
- blisters
- rash
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.
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.
Ask A Doctor Before Use If You Have
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
Ask A Doctor Or Pharmacist Before Use If You Are Taking The Blood Thinning Drug Warfarin.
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin.
When Using This Product Do Not Exceed Recommended Dosage.
When using this product do not exceed recommended dosage.
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
- new symptons occur
- redness or swelling is present
- pain, cough or nasal congestion gest worse or lasts for more than 7 days
- fever gets worse or lasts more than 3 days
- nervousness, dizziness, or sleeplessness occur
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding, Ask A Health Professional Before Use.
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
Directions
- do not take more than directed
Adults and children: (12 years and older)
Take 2 caplets every 4 hours
Do not to take more than 10 caplets in 24 hours
Children under 12 years: ask a doctor
Other 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 Ingredients
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
Questions
Questions? 1-800-835-2263
Physicians Care Cold & Cough
91462
PhysiciansCare®
Non-Drowsy
Cold & Cough
Cold, Cough and Flu Relief
Pull
to Open
COATED CAPLET
Individually packaged for workplace use
Tamper-Evident Packets of 2 Caplets
Do not use if packet is open or torn.
Not Actual Size
100 Caplets (50 Packets, 2 caplets each)
* Please review the disclaimer below.
