Kroger nitetime flu plus severe cold and cough powder, for solution

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • runny nose
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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

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

  • in a child under 4 years of age
  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a sodium-restricted diet
  • 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 aretaking

  • sedatives or tranquilizers
  • 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.

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding,ask a heath 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.

Directions

  • do not use more than directed
  • take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor
    Age Dose
    children under 4 years of age do not use
    children 4 to under 12 years of age do not use unless directed by a doctor
    adults and children 12 years of age and over one packet
  • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
  • 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 4 mg, sodium 27 mg
  • phenylketonurics:contains phenylalanine 34 mg per packet
  • store at controlled room temperature 20-25C (68-77F). Protect product from heat and moisture.

Inactive ingredients

acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.

Questions or comments?

Call 1-800-632-6900

Spl unclassified section

DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO 45202

Ingredients and appearance - Product information

Kroger nitetime flu plus severe cold and cough powder, for solution- Acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 30142-113
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 potassium ( UNII: 23OV73Q5G9)
Aspartame ( UNII: Z0H242BBR1)
Anhydrous citric acid ( UNII: XF417D3PSL)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Maltodextrin ( UNII: 7CVR7L4A2D)
Anhydrous trisodium citrate ( UNII: RS7A450LGA)
Sucrose ( UNII: C151H8M554)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Kroger Company( 006999528)

Principal display panel - 6 packet carton

COMPARE TOthe active ingredients of THERAFLU ®
NIGHTTIME SEVERE COLD & COUGH
*See side panel

SEE NEW WARNINGS
INFORMATION & DIRECTIONS

NDC 30142-113-07

Kroger ®

FROM OUR FAMILY
TO YOURS

NiteTime

Flu + Severe
Cold & Cough

Acetaminophen,Pain Reliever/Fever Reducer
Diphenhydramine HCl, Antihistamine/Cough Suppressant
Phenylephrine HCl, Nasal Decongestant

  • Nasal Congestion
  • Sore Throat Pain
  • Runny Nose
  • Body Ache
  • Fever
  • Headache
  • Cough
  • Sneezing

Our Pharmacists
Recommend

6
PACKETS

HONEY
LEMON

INFUSED WITH
CHAMOMILE &
WHITE TEA FLAVORS