ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE capsule, liquid filled

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate by

Drug Labeling and Warnings

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate by is a Otc medication manufactured, distributed, or labeled by ONE2ZEE LIMITED LIABILITY COMPANY, Medgel Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine Hydrochloride 5 mg

Doxylamine Succinate 6.25 mg

Purpose

Pain reliever/ fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

• temporarily relieves common cold/flu symptoms:

    ο nasal congestion
    ο sinus congestion & pressure
    ο cough due to minor throat & bronchial irritation
    ο minor aches & pains
    ο headache
    ο fever
    ο sore throat

• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warning

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

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 to sedate children.

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
• in children under 12 years of age

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• cough with excessive phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

When using this product

• do not exceed recommended dosage
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

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 headache that lasts.

These could be signs of a serious condition.

• nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. 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.

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

Direction

• take only as directed - see Overdose warning
• do not exceed 4 doses per 24 hours

• adults & children 12 years of age and over: 2 softgels with water every 4 hours
• Children under 12 years of age: ask a doctor

When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Other Information:

• store at room temperature 59°-86°F (15°-30°C)

Inactive ingredients

polyethylene glycol 400, propylene glycol, povidone k30, sodium hydroxide, FD&C blue #1, D&C yellow #10, titanium dioxide, gelatin, glycerin, sorbitol, water

PRINCIPAL DISPLAY PANEL - Shipping Label

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCL, Doxylamine Succinate capsules

Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Phenylephrine Hydrochloride USP 5mg, Doxylamine Succinate 6.25 mg)

LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-016-
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.

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE 
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55629-016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE K30 (UNII: U725QWY32X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	green	Score	no score
Shape	capsule	Size	21mm
Flavor		Imprint Code	IS5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55629-016-01	48 in 1 CARTON	03/02/2021
1	NDC: 55629-016-02	300 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/02/2021

Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)

Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)

Establishment
Name	Address	ID/FEI	Business Operations
Medgel Private Limited		677385498	manufacture(55629-016)