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Name:Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Manufacturer:Spirit Pharmaceuticals, Llc
Category:Over-the-counter (OTC) Marketed Drugs


Acetaminophen, Dextromethorpan HBr & Phenylephrine HCL capsule

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE - acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled 
SPIRIT PHARMACEUTICALS, 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.

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Acetaminophen, Dextromethorpan HBr & Phenylephrine HCL capsule

Drug Facts

Active ingredients (in each LiquiCap) 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

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with other medicines containing acetaminophen
  • 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

  • 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

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 the recommended dose 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 as well as for children even if you do not notice any signs or symptoms.

Directions

  • take only as recommended - see Overdose warning
  • do not exceed 6 doses per 24 hours
adults and children 12 years and over 2 LiquiCaps with water every 4 hours
children under 12 years ask a doctor
  • when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

Other information

  • store at room temperature

Inactive ingredients

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions?

1-800-251-3374

PRINCIPAL DISPLAY PANEL

Acetaminophen, Dextromethorphan HBr Phenylephrine HCL capsules

Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg,
Phenylephrine Hydrochloride USP 5mg)

LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 68210-0101-
EXP DATE:

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE: 35916
LIC NO.: TN/DRUGS/00002124

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION: "FOR MANUFACTURING, PROCESSING OR REPACKING"

  • 1 – 4
  • 2 – 100
  • 3 – 1000
  • 4 – 5000
  • 5 – 10000
    6 - 2500
PRINCIPAL DISPLAY PANEL

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE  
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0101
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
POLYETHYLENE GLYCOL 400  
POLYETHYLENE GLYCOL 600  
GELATIN  
POVIDONE  
SORBITOL  
WATER  
BUTYLATED HYDROXYANISOLE  
BUTYLATED HYDROXYTOLUENE  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 20mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-0101-1 4 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOX None
2 NDC:68210-0101-2 100 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOX None
3 NDC:68210-0101-3 1000 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOX None
4 NDC:68210-0101-4 5000 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOX None
5 NDC:68210-0101-5 10000 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOX None
6 NDC:68210-0101-6 2500 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOX None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 10/15/2009

Labeler - SPIRIT PHARMACEUTICALS, LLC (179621011)

Revised: 09/2010 SPIRIT PHARMACEUTICALS, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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