COMBINATION PACK TOPCARE HEALTH DAYTIME SEVERE AND NITETIME SEVERE COLD AND FLU RELIEF SOFTGELS - 24 CT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, phenylephrine hydrochloride kit

COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct by

Drug Labeling and Warnings

COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAYTIME SEVERE COLD AND FLU RELIEF

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

 temporarily relieves common cold/flu symptoms:
  nasal congestion                sinus congestion & pressure 
  cough due to minor throat & bronchial irritation 
  minor aches & pains          head ache 
  fever                                  sore throat 
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

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 heart disease high blood pressure
thyroid disease diabetes  glaucoma
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, chronic bronchitis or emphysema

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

When using this product, do not use more than directed.

Stop use and ask a doctor if
you get nervous, dizzy, or sleepless
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 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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

 take only as directed
 do not exceed 8 softgels per 24 hrs

• adults & children 12 yrs and 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 controlled room temperature between 20-25°C (68-77°F)
protect from light, heat, and moisture

Inactive ingredients

FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

Call 1-888-423-0139

NITETIME SEVERE COLD AND FLU RELIEF

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

 temporarily relieves common cold/flu symptoms:
  nasal congestion                sinus congestion & pressure
   cough due to minor throat & bronchial irritation 
  cough to help you sleep      minor aches & pains
  headache      fever            sore throat 
  runny nose & sneezing        reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage

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        heart disease    high blood pressure
thyroid disease    diabetes          glaucoma
trouble urinating due to enlarged prostate gland
 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

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, and tranquilizers may increase drowsiness

Stop use and ask a doctor if
 you get nervous, dizzy, or sleepless
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 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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

 take only as directed
 do not exceed 8 softgels per 24 hours

• adults & children 12 yrs and 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 controlled room temperature between 20-25°C (68-77°F)
protect from light, heat, and moisture

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

COMPARE TO VICKS® DAYQUIL™ SEVERE COLD & FLU LIQUICAPS™ ACTIVE INGREDIENTS*

MULTI-SYMPTOM RELIEF

Antihistamine Free

COMPARE TO VICKS® NYQUIL™ SEVERE COLD & FLU LIQUICAPS™ ACTIVE INGREDIENTS*

*These products are not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks® DayQuil™ & NyQuil™ LiquiCaps™.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DO NOT TAKE THESE PRODUCTS AT THE SAME TIME

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO STVA0825

topcare@topco.com www.topcarebrand.com
PRODUCT OF INDIA

QUALITY GUARANTEED

This Topcare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

Packaging

INGREDIENTS AND APPEARANCE

COMBINATION PACK TOPCARE HEALTH DAYTIME SEVERE AND NITETIME SEVERE COLD AND FLU RELIEF SOFTGELS - 24 CT 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-678

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-678-24	1 in 1 CARTON; Type 0: Not a Combination Product	12/11/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	12
Part 2	1 BLISTER PACK	12

Part 1 of 2

DAYTIME SEVERE COLD AND FLU RELIEF SOFTGELS 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled

Product Information
Item Code (Source)	NDC: 76162-636
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	A13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	12/11/2025

Part 2 of 2

NITETIME SEVERE COLD AND FLU RELIEF SOFTGELS 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled

Product Information
Item Code (Source)	NDC: 76162-637
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	A07
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	12/11/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/11/2025

Labeler - Topco Associates LLC (006935977)