COLDTAC PLUS SOFTGELS- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Coldtac Plus Softgels by

Drug Labeling and Warnings

Coldtac Plus Softgels by is a Otc medication manufactured, distributed, or labeled by OPMX LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each Softgel)	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 & 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

Allergy alert

Acetaminophen may cause severe skin reactions. Symtoms 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, lasts 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
• Heart 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, chronic bronchitis 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 nervouz, 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 symtoms occur.
• Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

If pregnant or breast-feeding,

ask a health professional before use.

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

Directions

• Take only as directed.
• 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

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?

Call to free 619-600-5632 Monday throughFriday 9AM - 5PM EST

SPL UNCLASSIFIED SECTION

Made for:

RRX

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

PRINCIPAL DISPLAY PANEL

NDC: 69729-120-10

Coldtac Plus

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5mg

Pain reliever, fever reducer/ Fiebre y cuerpo cortado

Nasal Descongestant/ Descongestivo nasal

Cough Suppressant/ Supresor de la tos

Contents/Content

10 Softgels/ Capsulas de Gel

INGREDIENTS AND APPEARANCE

COLDTAC PLUS SOFTGELS 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-120
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	AP01
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-120-10	1 in 1 CARTON	06/30/2023
1		10 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	06/30/2023

Labeler - OPMX LLC. (029918743)