Quality Choice night time severe cold and cough honey lemon infused with chamomile and white tea flavors

Dosage form: granule, for solution
Ingredients: Acetaminophen 650mg, Diphenhydramine Hydrochloride 25mg, Phenylephrine Hydrochloride 10mg
Labeler: Quality Home Products
NDC Code: 64525-0550

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.

night time severe cold and cough honey lemon infused with chamomile and white tea flavors

Active ingredients (in each packet)                          Purpose

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

Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant

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

Uses

- temporarily relieves

          - minor aches and pains         - minor sore throat pain

          - headache                            - nasal and sinus congestion

          - runny nose                          - sneezing

          - itchy nose and throat            - itchy, watery eyes due to hay fever

          - 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.

Do not use

- with any other drug containing acetaminophen (prescription and non prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

- with any other product containing diphenhydramine, even one used on the skin

-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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before us if you have

- liver disease   - heart disease   - high blood pressure

- thyroid disease   - diabetes   - glaucoma

- trouble urinating due to an enlarged prostate gland

- a breathing problem such as emphysema, asthma, or chronic bronchitis

- cough that occurs with too much phlegm (mucus)

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

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers.
  • Taking the blood thinning drug warfarin

When using this product

- do not exceed recommended dosage

- avoid alcoholic drinks   - marked drowsiness may occur

- alcohol, sedatives and tranquilizers may increase drowsiness

- be careful when driving a motor vehicle or operating machinery

- excitability may occur, especially in children.

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 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

- 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 7 mg,

sodium 46 mg

- phenylketonurics: contains phenylalanine

13 mg per packet

- store at controlled room temperature

20-25C (68-77F). Protect from

excessive heat and moisture.

QUALITY CHOICE NIGHT TIME SEVERE COLD AND COUGH  HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS
acetaminophen, diphenhydramine hcl, and phenylephrine hcl. granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64525-0550
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg
Inactive Ingredients
Ingredient NameStrength
Acesulfame 
Aspartame 
citric acid monohydrate 
Maltodextrin 
Sodium Citrate 
Sucrose 
Product Characteristics
Coloryellow (Carmel Color) , yellow (D & C Yellow 10) Score    
ShapeSize
FlavorHONEY (Natural Honey & Lemon Flavor) , LEMON (Natural Honey & Lemon Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64525-0550-66 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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