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  5. Label Information: Shoprite Daytime Flu Plus Severe Cold And Cough

FDA Label for Shoprite Daytime Flu Plus Severe Cold And Cough

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. ALLERGY ALERT
    5. LIVER WARNING
    6. SORE THROAT WARNING
    7. DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    10. WHEN USING THIS PRODUCT
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS OR COMMENTS?
    18. PRINCIPAL DISPLAY PANEL - 6 PACKET CARTON

Shoprite Daytime Flu Plus Severe Cold And Cough Product Label

The following document was submitted to the FDA by the labeler of this product Wakefern Food Corporation. 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.

Other



Drug Facts

Distributed By: Wakefern Food Corp.
5000 Riverside Drive
Keasbey, NJ 08832


Otc - Purpose



Active ingredients (in each packet)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 20 mgCough suppressant
Phenylephrine hydrochloride 10 mgNasal decongestant

Uses



  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation
    • temporarily reduces fever

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.
  • 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
  • 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

Ask 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
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health care professional before 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. 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, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor
    • AgeDose
    children under 4 years of agedo not use
    children 4 to under 12 years of agedo not use unless directed by a doctor
    adults and children 12 years of age and overone 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°-25°C (68°-77°F). Protect product from heat and moisture.

Inactive Ingredients



acesulfame potassium, aspartame, citric acid anhydrous, 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-ShopRite


Principal Display Panel - 6 Packet Carton



Compare to: Active Ingredients in Theraflu® Daytime Severe Cold & Cough

See New Warnings
Information & Directions

ShopRite®

Daytime

FLU & SEVERE
COLD & COUGH

ACETAMINOPHEN
Pain Reliever/Fever Reducer

DEXTROMETHORPHAN HBr
Cough Suppressant

PHENYLEPHRINE HCl
Nasal Decongestant

Nasal & Sinus Congestion, Cough, Body Ache,
Sore Throat Pain, Headache, Fever

Berry Infused
with Menthol & Green Tea Flavor

6 PACKETS

Principal Display Panel - 6 Packet Carton - daytime 01

Principal Display Panel - 6 Packet Carton - daytime 01


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