ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE capsule, liquid filled

Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate by

Drug Labeling and Warnings

Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate by is a Otc medication manufactured, distributed, or labeled by Softgel Healthcare Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients(in each Softgel)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 15 mg

Doxylamine succinate USP 6.25 mg

Purpose

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
• runny nose & sneezing

Warnings

Liver warning:

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

• more than 8 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 reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin 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.

Ask a doctor before use if you have

• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

• pain 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

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 directed
• do not exceed 8 softgels per 24 hrs

• adults & children 12 yrs & over: 2 softgels with water every 6 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

Other information

• store at no greater than 25ºC

Inactive ingredients

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, sorbitol sorbitan solution, water

TAMPER EVIDENT

This package is safety-sealed. Use only if blisters are intact. If difficult to open, use scissors.

Manufactured by

Softgel Healthcare Pvt Ltd.,

Survey no. 20/1, Vandalur-Kelambakkam Road,

Pudupakkam Village, Kancheepuram District,

Tamilnadu – 603103, India

Mfg. Lic. No: xxxxxxxxxxxxxx

PRINCIPAL DISPLAY PANEL

NDC Code: 35916-0154-1

*Compared to the active ingredient in VICKS ® NyQuil TM Cold & F Liquicaps TM

Acetaminophen 325 mg, Dextromethorphan Hbr 15 mg and Doxylamine Succinate 6.25 mg Softgelatin Capsules

Fever, Sore Throat, Headache, Minor Aches & Pains

Runny Nose & Sneezing

Cough

Night time

(Cold & Flu - 12 Softgels)

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE 
acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0154
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	green (transparent)	Score	no score
Shape	CAPSULE (Oblong square)	Size	21mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0154-1	1 in 1 CARTON	09/27/2024
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/27/2024

Labeler - Softgel Healthcare Private Limited (675584180)