FDA Label for Good Neighbor Pharmacy Cold Multi Symptom
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Good Neighbor Pharmacy Cold Multi Symptom Product Label
The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. 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.
Active Ingredient (In Each Caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
- for the temporary relief of the following cold/flu symptoms:
- minor aches and pains
- sore throat
- cough
- headache
- nasal congestion
- impulse to cough
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
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
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.
- 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
- liver disease
- thyroid disease
- diabetes
- heart disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When Using This Product
do not use more than directed
Stop Use And Ask A Doctor If
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts
- redness or swelling is present
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
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.
Directions
- do not take more than directed (see Liver warning)
- take 2 caplets every 4 hours
- swallow whole – do not crush, chew or dissolve
- do not take more than 12 caplets in 24 hours
- do not use this adult product in children under 12 years of age
adults and children 12 years and over | |
children under 12 years |
Other Information
- each caplet contains: sodium 3 mg
Inactive Ingredients
acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-800-719-9260
Principal Display Panel
See New Warnings Information
Compare To Active Ingredients In Tylenol® Cold Multi-Symptom Severe Cool Burst® Caplets
Cold
Multi-Symptom
Severe
Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Expectorant
Contains 4 Medicines:
Fever/Headache/Sore Throat – Acetaminophen
Nasal Congestion – Phenylephrine HCl
Coughing – Dextromethorphan HBr
Chest Congestion – Guaifenesin
Cool Ice® Instant Cooling Sensation
Daytime
Non-Drowsy
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