AXIM DayTime: Package Insert and Label Information

AXIM DAYTIME- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled
VIVUNT PHARMA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

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 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

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • 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

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dose

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • 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

Keep out of reach of children.

If pregnant or breast-feeding

ask a health professional before use.

Overdose warning

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Directions

  • Take only as directed see — overdose warning:
  • Do not take more than 8 Softgels in 24 hours.

adults & children 12 yrs & over 2 Softgels with water every 4 hrs
children 4 to under 12 yrs consult a doctor
children under 4 yrs do not use

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.

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

Product of India Distributed by:

VIVUNT PHARMA LLC 8950 SW 74th. Court. Suite 1901

Miami, Florida. Z,C. 33156-3178

PRINCIPAL DISPLAY PANEL — Axim DayTime Carton

Compare to

VICKS ® DayQuil™

Cold&Flu LiquiCaps

active ingredients*

NDC 82706-001-01

AXIM — DayTime

COLD&FLU

Multi-Symptom Relief

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Nasal Decongestant


Non-Drowsy

Acetaminophen , Phenylephrine HCl,

Dextromethorphan HBr

24 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by

The Procter &Gamble Company. Vicks® DayQuil®

and LiquiCaps™ are registered trademarks of

The Procter and Gamble Company

Axim Day Time
(click image for full-size original)
AXIM DAYTIME
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82706-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
PROPYLPARABEN
METHYLPARABEN
GLYCERIN
FD&C YELLOW NO. 6
FD&C RED NO. 40
GELATIN
POLYETHYLENE GLYCOL 400
POVIDONE K30
PROPYLENE GLYCOL
WATER
SORBITOL
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape OVAL Size 22mm
Flavor Imprint Code axim
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82706-001-01 24 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (82706-001-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/09/2022
Labeler — VIVUNT PHARMA LLC (045829437)

Revised: 05/2022 VIVUNT PHARMA LLC

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