Daytimenon drowsy capsule, liquid filled

Active ingredient (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  1. nasal congestion
  2. cough due to minor throat and bronchial irritation
  3. sore throat
  4. headache
  5. minor aches and pains
  6. fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  1. more than 12 softgels in 24 hours, which is the maximum daily amount
  2. with other drugs containing acetaminophen
  3. 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

  1. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  2. 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.

Ask a doctor before use if you have

  1. liver disease
  2. heart disease
  3. thyroid disease
  4. diabetes
  5. high blood pressure
  6. trouble urinating due to an enlarged prostate gland
  7. cough that occurs with too much phlegm (mucus)
  8. persistent or chronic cough 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 use more than directed

Stop use and ask a doctor if

  1. you get nervous, dizzy or sleepless
  2. pain, nasal congestion or cough gets worse or lasts more than 7 days
  3. fever gets worse or lasts more than 3 days
  4. redness or swelling is present
  5. new symptoms occur
  6. 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.

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

  1. take only as recommended see Liver warning
  2. do not exceed 6 doses per 24 hours

adults and children 12 years and over

2 softgels with water every 4 hours

children 4 to under 12 years

ask a doctor

children under 4 years

do not use

  1. when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Inactive ingredients

edible ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

1-800-213-9040

Ingredients and appearance - Product information

Daytimenon drowsy capsule, liquid filled- Acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 41268-215
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 10 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Gelatin ( UNII: 2G86QN327L)
Glycerin ( UNII: PDC6A3C0OX)
Mannitol ( UNII: 3OWL53L36A)
Povidones ( UNII: FZ989GH94E)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sorbitan ( UNII: 6O92ICV9RU)
Sorbitol ( UNII: 506T60A25R)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)

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 - Hannaford Brothers Company( 006949556)

Principal display panel

Compare to Vicks® DayQuil® LiquiCaps® active ingredients

SEE NEW WARNINGS INFORMATION

Nasal Decongestant/Cough Suppressant

Pain Reliever/Fever Reducer

DayTime

Multi-Symptom - Cold & Flu

Non-Drowsy

Aches, Fever - Acetaminophen

Cough - Dextromethorphan HBr

Nasal Congestion - Phenylephrine HCl

Alcohol Free - Antihistamine Free

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