Night Time Cold/flu Relief Cherry (Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate) Liquid [Kareway Product, Inc.] -

NIGHT TIME COLD/FLU RELIEF CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]
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NDC	67510-1507-0, 67510-1507-2, 67510-1507-4, 67510-1507-6
Set ID	36263ccb-c5b2-42e0-bc16-b4b4000671bc
Category	HUMAN OTC DRUG LABEL
Packager	Kareway Product, Inc.
Generic Name
Product Class	Antihistamine
Product Number
Application Number	PART341

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Active ingredients (in each 30 ml dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
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 daily while using this product
Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
- to make a child sleep
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
- a sodium-restricted diet
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
- 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.
If pregnant or breast-feeding,

ask a health professional before use.
Keep out of reach of children.
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 as for children even if you do not notice any signs or symptoms.
Directions
- take only as directed - see Overdose warning
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
adults and children 12 yrs and over
30 ml (2 Tbsp) every 6 hours

children 4 to under 12 yrs
ask a doctor

children under 4 yrs
do not use
Other information
- each 30 mL dose cup contains: sodium 43 mg
- store at room temperature
Inactive ingredients

alcohol, citric acid, FD and C blue no.1, FD and C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose, xanthan gum
Package label

Night Time Cold/Flu Relief Cherry

INGREDIENTS AND APPEARANCE

NIGHT TIME COLD/FLU RELIEF CHERRY
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67510-1507
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 30 mL
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

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description
Packaging
1	NDC:67510-1507-4	120 mL in 1 BOTTLE
2	NDC:67510-1507-6	177 mL in 1 BOTTLE
3	NDC:67510-1507-0	295 mL in 1 BOTTLE
4	NDC:67510-1507-2	354 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/11/2012

Labeler - Kareway Product, Inc. (121840057)

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Medic

NIGHT TIME COLD/FLU RELIEF CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KAREWAY PRODUCT, INC.]

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

Related Drugs

adults and children 12 yrs and over	30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use