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Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride

Medically reviewed on May 30, 2017

Dosage form: capsule, liquid filled
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 5mg, ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg
Labeler: Granules India Limited
NDC Code: 62207-912

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.

Acetaminophen 325 mg
Dextromethorphan Hydrobromide 10 mg
Phenylephrine Hydrochloride 5 mg

Active ingredient

(in each Softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

• temporarily relieves these symptoms due to cold and flu:
sneezing
itching of the nose, throat or watery eyes due to hay fever
cough
nasal congestion
sinus congestion and pressure
sore throat
head ache
minor aches and pains
• helps clear nasal passages and shrinks swollen membranes
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take
• more than 10 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

Allergy alert

acetaminophen may cause severe skin or severe allergic reactions. Symptoms may
include:
• skin reddening

• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock
If a skin or allergic reaction occurs, stop use and seek medical help right away.

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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• if you ever had an allergic reaction to this product or any of its ingredients.
• in children 12 years of age.

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• cough with excess phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough 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 dosage

Stop use and ask a doctor if

• pain, cough, or nasal congestion 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 head ache that lasts for 1 week, these could be the signs of serious condition
• nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding

ask a health professional before use

Keep out of the reach of children

In case of overdose, get medical help or contact 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

Do not take more than the recommended dose
adults & children under 12 years and over
- take 2 softgels with water every 4 hours.
- do not exceed 10 softgels in 24 hours or as directed by a doctor
children under 12 years
- do not use

Other information

• store in a cool and dry place.
• protect from sunlight.
• Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org

Inactive ingredients

FD&C Blue 1, FD&C Red 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan, titanium dioxide

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

Daytime Softgels

ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE HYDROCHLORIDE 
acetaminophen dextromethorphan hydrobromide phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-912
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
POVIDONE 
GLYCERIN 
SODIUM HYDROXIDE 
SORBITOL 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize20mm
FlavorImprint CodeG02
Contains    
Packaging
#Item CodePackage Description
1NDC:62207-912-6912 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/07/2017
Labeler - Granules India Limited (915000087)

 
Granules India Limited

← See all Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride brands

Further information

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

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