SPL v5
SPL
SPL Set ID c8e9b57b-83e9-46c5-9791-02c4c2b94004
Route
ORAL
Published
Effective Date 2014-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Diphenhydramine (12.5 mg) Phenylephrine (5 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Maltitol Propylene Glycol Water Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-10-04

Description

Active ingredients (in each tablespoonful 15 mL) Acetaminophen 325 mg Diphenhydramine HCL  12.5 mg Phenylephrine HCL 5mg

Purpose

Pain reliever/Fever reducer Cough suppressant/Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant/Antihistamine

Nasal decongestant

Description

Active ingredients (in each tablespoonful 15 mL) Acetaminophen 325 mg Diphenhydramine HCL  12.5 mg Phenylephrine HCL 5mg

Uses

temporarily relieves these common cold and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • nasal and sinus congestion
  • runny nose
  • sneezing
  • itchy watery eyes
  • itchy nose or throat
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever



Warnings

Liver warnings: This product contains acetaminophen.



Severe liver damage may occur if you take:

  • more than 6 dose in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Directions

Age                                                                                  Dose



Children under 4 years                                                      Do not use



Children 4 to under 12 years of age                                    Do not use unless directed by a doctor



Adults and children 12 years and over                                2 tablespoonful (30 mL) every 4 hours

  • take only as recommended (see Overdose warning)
  • use dose cup or tablespoon (TBSP)
  • do not take more than 6 doses in any 24-hour period
Do Not Use
  • 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 taking  a prescription monamine 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
  • with any other drug containing diphenhydramine, even one used on the skin

  • for children under 4 years of age
Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Product Label

NDC 6801-154-08



*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFUL® WARMING RELIEF COLD AND CHEST CONGESTION



Premier Value®



Night Time Severe Cold and Cough Relief



Acetaminophen ............ Pain Reliever/Fever Reducer

Diphenhydramine.......... Antihistamine/Cough Suppressant

Phenylephrine HCL ...... Nasal Congestion



    Fever and Body Aches

    Sore Throat

    Headache

    Nasal Congestion

    Runny Nose

    Cough

   Cherry Flavor



8.3 FL OZ (245 mL)



PV  Independently Tested Satisfaction Guaranteed



LF-007



DO NOT USE IF PRINTED SEAL UNDER AP IS TORN OR MISSING

Failure to follow these warnings could result in consequences



LB-007



DISTRIBUTED BY CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD SUITE 101

BOCA RATON, FL 33431



Lot:

Exp:



*This product is not manufactured or distributed b Novartis Consumer health Inc., owner of the registered trademark Theraflu® Night Time













Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact the Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information
  • each tablespoon (15 mL) contains:  potassium 9 mg, sodium 6 mg
  • dosage cup provided
  • store between 20°-25° C (68°-7°7 F)
  • do not refrigerate
Inactive Ingredients

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate

When Using This Product
  • do not use more than directed (see overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcohol drinks
  • be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
Drug Facts Active Ingredients

Active ingredients

(in each tablespoonful 15 mL)

Acetaminophen 325 mg

Diphenhydramine HCL  12.5 mg

Phenylephrine HCL 5mg



If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children



Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or empysema
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are Taking
  • the blood thinning drug warfarin
  • sedatives or tranquilizers


Structured Label Content

Uses

temporarily relieves these common cold and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • nasal and sinus congestion
  • runny nose
  • sneezing
  • itchy watery eyes
  • itchy nose or throat
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever



Purpose

Pain reliever/Fever reducer

Cough suppressant/Antihistamine

Nasal decongestant

Warnings

Liver warnings: This product contains acetaminophen.



Severe liver damage may occur if you take:

  • more than 6 dose in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Directions

Age                                                                                  Dose



Children under 4 years                                                      Do not use



Children 4 to under 12 years of age                                    Do not use unless directed by a doctor



Adults and children 12 years and over                                2 tablespoonful (30 mL) every 4 hours

  • take only as recommended (see Overdose warning)
  • use dose cup or tablespoon (TBSP)
  • do not take more than 6 doses in any 24-hour period
Do Not Use (Do not use)
  • 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 taking  a prescription monamine 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
  • with any other drug containing diphenhydramine, even one used on the skin

  • for children under 4 years of age
Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Product Label

NDC 6801-154-08



*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFUL® WARMING RELIEF COLD AND CHEST CONGESTION



Premier Value®



Night Time Severe Cold and Cough Relief



Acetaminophen ............ Pain Reliever/Fever Reducer

Diphenhydramine.......... Antihistamine/Cough Suppressant

Phenylephrine HCL ...... Nasal Congestion



    Fever and Body Aches

    Sore Throat

    Headache

    Nasal Congestion

    Runny Nose

    Cough

   Cherry Flavor



8.3 FL OZ (245 mL)



PV  Independently Tested Satisfaction Guaranteed



LF-007



DO NOT USE IF PRINTED SEAL UNDER AP IS TORN OR MISSING

Failure to follow these warnings could result in consequences



LB-007



DISTRIBUTED BY CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD SUITE 101

BOCA RATON, FL 33431



Lot:

Exp:



*This product is not manufactured or distributed b Novartis Consumer health Inc., owner of the registered trademark Theraflu® Night Time













Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact the Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • each tablespoon (15 mL) contains:  potassium 9 mg, sodium 6 mg
  • dosage cup provided
  • store between 20°-25° C (68°-7°7 F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate

When Using This Product (When using this product)
  • do not use more than directed (see overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcohol drinks
  • be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
Drug Facts Active Ingredients (Drug facts Active ingredients)

Active ingredients

(in each tablespoonful 15 mL)

Acetaminophen 325 mg

Diphenhydramine HCL  12.5 mg

Phenylephrine HCL 5mg



If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children



Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or empysema
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)
  • the blood thinning drug warfarin
  • sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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