NIGHTTIME COLD AND FLU- acetaminophen, dextromethrophan hbr, doxylamine succinate liquid

Nighttime Cold and Flu by

Drug Labeling and Warnings

Nighttime Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Kroger, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

PURPOSE

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

INDICATIONS & USAGE

Uses temporarily relieves common cold/flu symptoms:

-cough due to minor throat and bronchial irritation
-sore throat
-headache
-minor aches and pains
-fever
-runny nose and sneezing

WARNINGS

Warnings

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

-more than 4 doses 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

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
-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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

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

WHEN USING

When using this product

-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, and tranquilizers may increase drowsiness

STOP USE

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.

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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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

• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over-30 mL every 6 hrs

children 4 to under 12 yrs-ask a doctor

children under 4 yrs-do not use

OTHER SAFETY INFORMATION

Other information

• each 30 mL contains: sodium 52 mg
• store at no greater than 25°C and do not refrigerate

INACTIVE INGREDIENT

Inactive ingredients alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

QUESTIONS

Questions or comments? Call 1-800-632-6900

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NIGHTTIME COLD AND FLU 
acetaminophen, dextromethrophan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-750
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	red (clear red color)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-750-01	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/30/2024

Labeler - Kroger (006999528)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		677604129	manufacture(41226-750)