COLD, FLU AND SORE THROAT RELIEF- acetaminophen 650 mg, dextromethorphan hbr 20 mg, guaifenesin 400 mg, phenylephrine hcl 10 mg liquid

COLD, FLU and SORE THROAT RELIEF by

Drug Labeling and Warnings

COLD, FLU and SORE THROAT RELIEF by is a Otc medication manufactured, distributed, or labeled by BETTER LIVING BRANDS, LLC, TIME CAP LABORATORIES, INC, MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

PURPOSE

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

INDICATIONS & USAGE

Uses
■ temporarily relieves these common cold and flu
symptoms:
■ cough
■ nasal congestion
■ minor aches and pains
■ sore throat
■ headache
■ stuffy nose
■ sinus congestion and pressure
■ temporarily reduces fever
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 6 doses in 24 hours, which is the maximum daily amount
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks daily 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

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 DOCTOR

Ask a doctor before use if you have
■ liver disease
■ heart disease
■ diabetes
■ high blood pressure
■ thyroid disease
■ trouble urinating due to an enlarged prostate gland
■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
■ cough that occurs with too much phlegm (mucus)

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

WHEN USING

When using this product do not use more than directed

STOP USE

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur
■ pain, nasal congestion, 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 fever, rash, or headache that lasts.
These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions
■ do not take more than directed (see Overdose warning)
■ do not take more than 6 doses in any 24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
■ children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information
■ each 20 mL contains: sodium 15 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate

INACTIVE INGREDIENT

Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

QUESTIONS

Questions or comments?
Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD, FLU AND SORE THROAT RELIEF 
acetaminophen 650 mg, dextromethorphan hbr 20 mg, guaifenesin 400 mg, phenylephrine hcl 10 mg liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-909
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYL GALLATE (UNII: 8D4SNN7V92)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-909-03	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2025

Labeler - BETTER LIVING BRANDS, LLC (009137209)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		677604129	manufacture(21130-909)