MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME- acetaminophen dextromethorphan hbr phenylephrine hcl and acetominophen dextromethorphan hbr doxylamine succinate kit

MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME by

Drug Labeling and Warnings

MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME by is a Otc medication manufactured, distributed, or labeled by RITE AID, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

daytime cold &flu
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

nighttime cold &flu
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

PURPOSE

daytime cold & flu
Purpose
Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant

nighttime cold & flu
Purpose
Pain reliever/Fever reducer
Cough suppressant
Antihistamine

INDICATIONS & USAGE

Uses
temporarily relieves common cold/flu symptoms:

• nasal congestion (Daytime only)
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
• runny nose & sneezing (Nithttime only)

WARNINGS

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
• wtth 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

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 (nighttime only)
• heart disease (Daytime only)
• high blood pressure (Daytime only)
• thyroid disease (Daytime only)
• diabetes (Daytime only)
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
• a breathing problem or chronic cough that lasts or as occurs wtth smoking, asthma, chronic bronchitis or emphysema (nighttime only)

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

• taking the blood thining drug warfarin

WHEN USING

When using this product, do not use more than directed.(daytime only)

• excitability may occur, especially in children (nighttime only)
• marked drowsiness may occur (nighttime only)
• avoid alcoholic drinks (nighttime only)
• be carefull when driving a motor vehicle or operating machinery. (nighttime only)
• alcohol, sedatives, & tranquilizers may increase drowsiness. (nighttime only)

STOP USE

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless (daytime only)
• pain, nasal congestion or cough get worse or last more than 7 days (daytime only)
• pain or cough gets worse or lasts more than 7 days (nighttime only)
• 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 right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• take only as directed
• do not exceed 4 doses per 24 hours

adults & children 12 yrs & over: 2 softgels with water every 4 hrs (daytime only)
adults & children 12 yrs & over: 2 softgels with water every 6 hrs (nighttime only)
children 4 to under 12 yrs:ask a doctor
children under 4 yrs:do not use

OTHER INFORMATION

Other information

• store at room temperature

INACTIVE INGREDIENT

daytime cold & flu

Inactive ingredients FD&C red#40, FD&C yellow#6, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

nighttime cold & flu

Inactive ingredients FD&C blue#1, D&C yellow#10, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

QUESTIONS

Questions?call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME 
acetaminophen dextromethorphan hbr phenylephrine hcl and acetominophen dextromethorphan hbr doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-1988

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-1988-0	2 in 1 CARTON	09/15/2021
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11822-1988-9	4 in 1 CARTON	09/15/2021
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		16
Part 2		8

Part 1 of 2

MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME 
acetaminophen 325 mg dextromethorphan hbr 10 mg phenylephrine hci 5 mg capsule, liquid filled

Product Information
Item Code (Source)	NDC: 11822-1989
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SORBITAN (UNII: 6O92ICV9RU)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL (OBLONG SHAPED)	Size	21mm
Flavor		Imprint Code	70
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/15/2021

Part 2 of 2

MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME 
acetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg capsule, liquid filled

Product Information
Item Code (Source)	NDC: 11822-1987
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SORBITAN (UNII: 6O92ICV9RU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	71
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/15/2021

Labeler - RITE AID (014578892)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(11822-1988)