Rite Aid day time severe cold and cough berry infused with menthol and green tea flavors

Dosage form: granule, for solution
Ingredients: Acetaminophen 650mg, Dextromethorphan Hydrobromide 20mg, Phenylephrine Hydrochloride 10mg
Labeler: Quality Home Products
NDC Code: 64525-0551

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Day time Severe Cold and cough berry infused with menthol and green tea flavors

Active ingredients (in each packet)                        Purpose

Acetaminophen 650 mg .........................Pain reliever-Fever reducer

Dextromethorphan hydrobromide 20 mg ..............Cough suppresant

Phenylephrine hydrochloride 10 mg...................Nasal decongestant

Uses

-Temporarily relieves:

    -minor aches and pains   -headache   -minor sore throat pain

    -nasal and sinus congestion   -cough due to minor throat and bronchial irritation

-Temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

-more than 6 packets in 24 hours

-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.


Ask a doctor before us if you have

-liver disease    -heart disease   -high blood pressure

-thyroid disease   -diabetes   -trouble urinating due to an enlarged prostate gland

-cough that occurs with too much phlegm (mucus)

-cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.

As 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

-nervousness, dizziness, or sleeplessness occurs   -fever gets worse or lasts more than 3 days

-redness or swelling is present

-new symptoms occur

-symptoms do not get better or worsen

-pain, cough or nasal congestion gets worse or lasts more than 7 days

-cough comes back or occurs with fever, rash or headache that lasts.

These could be signs of a serious condition

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children

In care 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

-do not use more than directed

-take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor

-adults and children 12 years of age and over; dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.

-children under 12 years of age: consult a doctor

-if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other information

-each packet contains:potassium 8 mg, sodium 20 mg

-phenylketonurics: contains phenylalanine 14 mg per packet

-store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.

RITE AID DAY TIME SEVERE COLD AND COUGH   BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS
acetaminophen, dextromethorphan hbr, and phenylephrine hcl. granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64525-0551
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg
Dextromethorphan Hydrobromide (Dextrose) Dextromethorphan Hydrobromide20 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg
Inactive Ingredients
Ingredient NameStrength
Acesulfame 
Aspartame 
citric acid monohydrate 
Maltodextrin 
Sodium Citrate 
Sucrose 
Product Characteristics
Colorred (FD & C red No. 40) , blue (FD & C blue No.1) Score    
ShapeSize
FlavorBERRY (Berry infused with menthol & Green tea flavors) , MENTHOL (menthol) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64525-0551-66 GRANULE, FOR SOLUTION (POUCH) in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/31/2009
Labeler - Quality Home Products (205554157)

Revised: 10/2009
 
Quality Home Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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