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Daytime Cold and Flu Relief by AiPing Pharmaceutical, Inc.

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: AiPing Pharmaceutical, Inc.
NDC Code: 11788-016

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.

Daytime Cold and Flu Relief

ACTIVE INGREDIENTS (IN EACH SOFTGEL)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCI 5mg

PURPOSES

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

USES

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

WARNINGS

Liver warning

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

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Sore throat warning

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to 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 use more than directed.

Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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 directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

DIRECTIONS
  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 2 softgels with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs

do not use

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

OTHER INFORMATION
  • store at room temperature

TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

INACTIVE INGREDIENTS

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

QUESTIONS OR COMMENTS?

Call toll free 1-844-374-0016

PRINCIPAL DISPLAY PANEL

*Compare to active ingredients in Vicks® Dayquil® Cold & Flu LiquiCaps®

*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Dayquil® Cold & Flu Liquicaps®

Cold & Flu Multi-Symptom Relief

Acetaminophen/Dextromethrophan HBr/Phenylephrine HCI

  • Aches, Fever, Sore Throat
  • Nasal Congestion
  • Cough

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788

Manufactured by:

Anshi Pharmaceutical (Zhongshan) Inc., P.R. China

DAYTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hci capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-016
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
GELATIN 
GLYCERIN 
FD&C RED NO. 40 
POLYETHYLENE GLYCOL 400 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
FD&C YELLOW NO. 6 
Product Characteristics
ColororangeScoreno score
ShapeOVALSize20mm
FlavorImprint CodeAP016
Contains    
Packaging
#Item CodePackage Description
1NDC:11788-016-061 BLISTER PACK in 1 BOX
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/31/2015
Labeler - AiPing Pharmaceutical, Inc. (079674526)
Registrant - AiPing Pharmaceutical, Inc. (079674526)
Establishment
NameAddressID/FEIOperations
Anshi Pharmaceutical (Zhongshan) Inc.528101821manufacture(11788-016)

 
AiPing Pharmaceutical, Inc.

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Medically reviewed on Oct 17, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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