Axiv Daytime & Nighttime

Axiv Daytime & Nighttime
SPL v2
SPL
SPL Set ID 1320e243-344f-98ed-e063-6294a90a0092
Route
ORAL
Published
Effective Date 2024-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Doxylamine (15 mg)
Inactive Ingredients
Propylparaben Methylparaben Water Gelatin Glycerin Titanium Dioxide Povidone K30 Polyethylene Glycol 400 Propylene Glycol Food Yellow 3 Free Acid Fd&c Red No. 40 Sorbitol Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: AXIV Shape: oval Color: orange Color: green Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-08
Description

Day Time Drug Facts

Medication Information

Description

Day Time Drug Facts

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
Section 42229-5

Day Time

Drug Facts

Section 55105-1
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg

Pain Reliever-fever reducer
Dextrometrophan HBr 10 mg Cough Suppressant

Directions
  • Take only as directed (see overdose warning):
  • Do not take more than 8 softgels in 24 hours.

adults and children 12 years and over

 2 softgels with water every 4 hours

children 4 to under 12 years

 consult a doctor
children under 4 years 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 or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Allergy Alert

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.

Liver Warning

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

  • more than 8 Softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Overdose Warning

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Other Information
  • Store at 20° - 25 °C (68 °- 77 °F)
  • Read all product information before using
  • Tamper evident: Do not use if the foil printed on the blister is torn or ripped
Sore Throat Warning

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.

Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No. 6, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

When Using This Product

do not exceed recommended dose

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

Keep out of reach of children.

Ask A Doctor Before Use If You Have
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
Principal Display Panel 48 Caps Day&night

Compare to Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-017-01

AXIV

DayTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant

Acetaminophen, Dextromethorphan HBr

32 SOFTGELS** **Liquid-filled capsules



NightTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

16 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®.

Principal Display Panel 72 Caps Day&night

Compare to Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-018-01

AXIV

DayTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant

Acetaminophen, Dextromethorphan HBr

48 SOFTGELS** **Liquid-filled capsules



NightTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

24 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
Section 42229-5 (42229-5)

Day Time

Drug Facts

Section 55105-1 (55105-1)
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg

Pain Reliever-fever reducer
Dextrometrophan HBr 10 mg Cough Suppressant

Directions
  • Take only as directed (see overdose warning):
  • Do not take more than 8 softgels in 24 hours.

adults and children 12 years and over

 2 softgels with water every 4 hours

children 4 to under 12 years

 consult a doctor
children under 4 years do not use

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 or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Allergy Alert

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.

Liver Warning (Liver warning)

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

  • more than 8 Softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Overdose Warning (Overdose warning)

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Other Information (Other information)
  • Store at 20° - 25 °C (68 °- 77 °F)
  • Read all product information before using
  • Tamper evident: Do not use if the foil printed on the blister is torn or ripped
Sore Throat Warning (Sore throat warning)

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.

Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, FD&C Yellow No. 6, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

When Using This Product (When using this product)

do not exceed recommended dose

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)

Keep out of reach of children.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
Principal Display Panel 48 Caps Day&night (PRINCIPAL DISPLAY PANEL - 48 Caps Day&Night)

Compare to Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-017-01

AXIV

DayTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant

Acetaminophen, Dextromethorphan HBr

32 SOFTGELS** **Liquid-filled capsules



NightTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

16 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®.

Principal Display Panel 72 Caps Day&night (PRINCIPAL DISPLAY PANEL - 72 Caps Day&Night)

Compare to Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-018-01

AXIV

DayTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant

Acetaminophen, Dextromethorphan HBr

48 SOFTGELS** **Liquid-filled capsules



NightTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

24 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:50.965079 · Updated: 2026-03-14T23:13:21.652895