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Daytime Cold and Flu Relief by ARMY AND AIR FORCE EXCHANGE SERVICE

Medically reviewed on July 27, 2017

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: ARMY AND AIR FORCE EXCHANGE SERVICE
NDC Code: 55301-534

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.

Exchange Select 44-534 Delisted

Active ingredients (in each liquid cap)

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 and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • fever
    • cough due to minor throat and bronchial irritation

Warnings

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

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 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
  • 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 don't 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
  • liver disease
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • 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: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed
    (see overdose warning)
  • do not take more than 4 doses per 24 hours
  • adults and children 12 years and over: take 2 liquid caps with water every 6 hours
  • children under 12 years: ask a doctor

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, white edible ink

Questions or comments?

1-800-426-9391

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Compare To The Active Ingredients of Vicks® DayQuil® LiquiCaps®*

Non-Drowsy

DAYTIME
Cold & Flu Relief
MULTI-SYMPTOM

Acetaminophen,

Dextromethorphan HBr, Phenylephrine HCl

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

24 Liquid Caps

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Liquicaps®.
50844    REV0113D53408
PRODUCT OF CANADA

"SATISFACTION GUARANTEED OR YOUR MONEY BACK"
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.
Hauppauge, NY 11788
1-800-426-9391

Exchange Select 44-534

DAYTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-534
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
WATER 
PROPYLENE GLYCOL 
POLYETHYLENE GLYCOLS 
POVIDONES 
Product Characteristics
ColorORANGE (Transparent) Scoreno score
ShapeCAPSULESize21mm
FlavorImprint Code95A
Contains    
Packaging
#Item CodePackage Description
1NDC:55301-534-082 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/19/200707/27/2018
Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
Establishment
NameAddressID/FEIOperations
Accucaps Industries, Ltd.248441727MANUFACTURE(55301-534)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55301-534)

 
ARMY AND AIR FORCE EXCHANGE SERVICE

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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