Daytime nitetime severe kit

Active ingredients (in each caplet) - nighttime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet) - daytime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose - nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Purpose - daytime

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses - nighttime

  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • sinus congestion and pressure
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

Uses - daytime

  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • sinus congestion and pressure
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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.

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

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

Ask a doctor before use if you have - daytime

  • 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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are - nighttime

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

Ask a doctor or pharmacist before use if you are - daytime

taking the blood thinning drug warfarin

When using this product - nighttime

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

When using this product - daytime

do not use more than directed

Stop use and ask a doctor if - nighttime

  • 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.

Stop use and ask a doctor if - daytime

  • 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 and daytime

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

adults & children 12 yrs & over

2 caplets with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information - nighttime

  • store at 20-25 C (68-77 F)

Other information - daytime

  • each caplet contains: sodium 4 mg
  • store at 20-25 C (68-77 F)

Inactive ingredients - nighttime

crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive ingredients - daytime

croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-632-6900

Ingredients and appearance - Product information

Daytime nitetime severe kit- Acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 30142-051
Route of Administration Oral

Product Characteristics

Color RED Size 19 mm
Shape OVAL Score 1
Imprint Code L922

Marketing Information

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

Labeler - Kroger Company( 006999528)

Package/label principal display panel - daytime

COMPARE TO the active ingredients of VICKS® DAYQUIL® SEVERE

See side panel

NON-Drowsy

DayTime

Severe Cold & Flu

Acetaminophen, Phenylephrine HCl,

Dextromethorphan HBr, Guaifenesin

Pain Reliever/Fever Reducer,

Nasal Decongestant,

Cough Suppressant, Expectorant

MAXIMUM STRENGTH RELIEF

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal/Sinus Congestion & Sinus Pressure

Cough

Chest Congestion

Our Pharmacists Recommend

16 DAYTIME SEVERE CAPLETS

actual size

COMPARE TO the active ingredients of VICKS® NYQUIL® SEVERE

See side panel

NiteTime

Severe Cold & Flu

Acetaminophen, Phenylephrine HCl,

Doxylamine Succinate, Dextromethorphan HBr

Pain Reliever, Fever Reducer,

Cough Suppressant, Antihistamine

Nasal Decongestant

MAXIMUM STRENGTH RELIEF

Our Pharmacists Recommend

8 NIGHTTIME SEVERE CAPLETS

actual size