Rite aid night time severe cold and coughhoney lemon with chamomile and white tea flavors granule, for solution

Otc - active ingredient section

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

Otc - purpose section

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 section

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.

Otc - do not use section

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.

Otc - ask doctor section

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.

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you are

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

Otc - when using section

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.

Otc - stop use section

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.

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

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.

Dosage & administration section

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.

Information for patients section

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.

Ingredients and appearance - Product information

Rite aid night time severe cold and coughhoney lemon with chamomile and white tea flavors granule, for solution- Acetaminophen, diphenhydramine hcl, and phenylephrine hcl.

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 64525-0552
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 650 mgin 1
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 25 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Acesulfame ( UNII: MA3UYZ6K1H)
Aspartame ( UNII: Z0H242BBR1)
Citric acid monohydrate ( UNII: 2968PHW8QP)
Maltodextrin ( UNII: 7CVR7L4A2D)
Sodium citrate ( UNII: 1Q73Q2JULR)
Sucrose ( UNII: C151H8M554)

Product Characteristics

Flavor LEMON (Natural Honey & Lemon Flavor) Color yellow (D & C Yellow 10)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Quality Home Products( 205554157)

Package label.principal display panel