FDA Label for Day Maximum Strength Cold And Flu Relief
View Indications, Usage & Precautions
- DRUG FACTS DAY MAXIMUM STRENGTH COLD AND FLU RELIEF
- OTC - ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- OTC - KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- DRUG FACTS - NIGHT MAXIMUM STRENGTH COLD AND FLU RELIEF
- DOSAGE FORMS & STRENGTHS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Day Maximum Strength Cold And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid. 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 Day Maximum Strength Cold And Flu Relief
DAY MAXIMUM STRENGTH COLD AND FLU RELIEF
Otc - Active Ingredient
Active ingredients (in each SOFTGEL)
- Acetaminophen 325 mg
- Dextromethorphan hydrobromide 10 mg
- Phenylephrine hydrochloride 5 mg
- Acetaminophen 325 mg
- Dextromethorphan Hydrobromide 10mg
- Doxylamine Succinate 6.25 mg
- Phenylephrine HCl 5 mg
Active ingredients in each softgel
Inactive Ingredient
Inactive ingredients: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
FD&C blue#1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Otc - Purpose
Purpose
- Pain reliever/fever reducer
- Cough suppressant
- Nasal decongestant
ACETAMINOPHEN/Pain Reliever-Fever Reducer
Dextromethorphan Hydrobromide/Cough Suppressant
Doxylamine Succinate/Antihistamine
Phenylephrine HCl/Nasal Decongestant
Indications & Usage
temporarily relieves these symptoms due to a cold or flu:
minor aches and pains · headache · cough
· sore throat · nasal and sinus congestion
temporarily reduces fever
temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains, headache, nasal and sinus congestion, cough, sore throat, runny nose, sneezing
temporarily reduces fever
Dosage & Administration
Directions:· do not take more than the recommended dose
· adults and children 12 years and over: take 2 softgels with water
every 4 hours.
Do not exceed 10 softgels in 24 hours or as directed by a doctor.
· children under 12 years: do not 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(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.
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.
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
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic 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
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
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic 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.
Drug Facts - Night Maximum Strength Cold And Flu Relief
NIGHT MAXIMUM STRENGTH COLD AND FLU RELIEF
Dosage Forms & Strengths
Directions:· do not take more than the recommended dose
· adults and children 12 years and over: take 2 softgels water every 4 hours. Do not exceed 10 softgels in 24 hours or as
directed by a doctor.
· children under 12 years: do not use
* Please review the disclaimer below.