Cold and fluday night kit

Active ingredients (in each softgel) nighttime cold & flu

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients (in each softgel) - daytime cold & flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose nighttime cold & flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose daytime cold & flu

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses nighttime cold & flu

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Uses daytime cold & flu

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains

fever

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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 Parkinsons 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have nighttime cold & flu

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you have daytime cold & flu

  • 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)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are nighttime cold & flu

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

Ask a doctor or pharmacist before use if you are daytime cold & flu

taking the blood thinning drug warfarin

When using this product nighttime cold & flu

do not use more than directed

Stop use and ask a doctor if nighttime cold & flu

  • 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.

Stop use and ask a doctor if daytime cold & flu

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion 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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions nighttime cold & flu

  • take only as directed see overdose warning
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Directions daytime cold & flu

  • take only as directed see overdose warning
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

  • store at 20-25 C (68-77 F)

Inactive ingredients nighttime cold & flu

D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Inactive ingredients daytime cold & flu

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Cold and fluday night kit- Acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 42507-208
Route of Administration Oral

Product Characteristics

Color ORANGE Size 20 mm
Shape CAPSULE Score 1
Imprint Code L994

Marketing Information

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

Labeler - HyVee Inc( 006925671)

Principal display panel - daytime

See New Warnings

COMPARE TO the Active Ingredients of Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®

Multi-Symptom Relief

Cold & Flu

Acetaminophen Pain Reliever/Fever Reducer

Dextromethorphan HBr Cough Suppressant

Phenylephrine HCl Nasal Decongestant

Daytime

Non-Drowsy

ACTUAL SIZE

Aches, Fever, Sore Throat

Cough

Nasal Congestion

Alcohol Free/Antihistamine Free

32 SOFTGELS

Principal display panel - nighttime

See New Warnings

COMPARE TO the Active Ingredients of Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®

Multi-Symptom Relief

Cold & Flu

Acetaminophen Pain Reliever/Fever Reducer

Dextromethorphan HBr Cough Suppressant

Doxylamine Succinate - Antihistamine

Nighttime

ACTUAL SIZE

Aches, Fever, Sore Throat

Cough

Sneezing/Runny Nose

16 SOFTGELS