Safeway Nighttime Cold & Flu

Safeway Nighttime Cold & Flu
SPL v4
SPL
SPL Set ID 45d44cd2-5187-4a5c-983a-edb1e8eba0b2
Route
ORAL
Published
Effective Date 2024-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitan Sorbitol Mannitol Lecithin, Soybean Light Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: PC10 Shape: oval Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-29

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistimine


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistimine

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 mg

Uses
  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
Warnings

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

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.

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.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
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 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 of pharmacist before taking this product.
Package Label
SIGNATURE SELECT Nighttime Cold & Flu Relief
Other Information
  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat
Inactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO Vick® NyQuil® Cold & Flu LiquiCaps® active ingredients*

NIGHTTIME MULTI-SYMPTOM

COLD & FLU RELIEF

ACETAMINOPHEN 325 mg -

Pain Reliever / Fever Reducer

DEXTROMETHORPHAN HBr 15 mg

- Cough Suppressant

DOXYLAMINE SUCCINATE 6.25 mg

- Antihistamine

Relieves aches, fever, sore throat, cough runny nose, sneezing

ALCOHOL-FREE

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, NyQuil®, and LiquiCaps® are registered trademarks of The Procter & Gamble Company

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1888-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have
  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Ask A Doctor of Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistimine

Warnings

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

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.

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.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
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 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 of pharmacist before taking this product.
Package Label
SIGNATURE SELECT Nighttime Cold & Flu Relief
Other Information
  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat
Inactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

Questions Or Comments? (Questions or Comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO Vick® NyQuil® Cold & Flu LiquiCaps® active ingredients*

NIGHTTIME MULTI-SYMPTOM

COLD & FLU RELIEF

ACETAMINOPHEN 325 mg -

Pain Reliever / Fever Reducer

DEXTROMETHORPHAN HBr 15 mg

- Cough Suppressant

DOXYLAMINE SUCCINATE 6.25 mg

- Antihistamine

Relieves aches, fever, sore throat, cough runny nose, sneezing

ALCOHOL-FREE

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, NyQuil®, and LiquiCaps® are registered trademarks of The Procter & Gamble Company

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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.)

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1888-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Softgel) (Active Ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Ask A Doctor of Pharmacist Before Use If You Are (Ask a doctor of pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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