COLD REMEDY SOOTHING - chlorpheniramine maleate, acetaminophen tablet 
International Nature Nutraceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Chlorphenamine Maleate 1.05 mg

Acetaminophen 105 mg

Uses

Temporarily relieve the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies:

Warnings

Do Not Use:

Ask a doctor or pharmacist before use if you are

While taking this product

Do not use this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product, may cause excitability, especially in children

May cause drowsiness. Alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

Avoid alcoholic beverages

Use caution when driving a motor vehicle or operating machinery.

Stop use and doctor if

Directions

Adults and children 12 years of age and older

Children ages 6 to 12 years old

Children under 6 years of age

Storage

Store at 15°C to 30°C (59°F to 86°F)

Keep away from heat

Store in a dry place

Keep out of reach of children

Inactive Ingredients

Lonicerae Flos, Weeping Forsythia Capsule, Fineleaf Schizonepeta Herb, Prepared Soybean, Lophatherum Herb, Great Burdock Achene, Reed Rhizome, Platycodon Root, Radix Glycyrrhizae, Vitamin C, Peppermint Oil.

Excipients:

Corn Starch, Stearic Acid, Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate, Betadex, Lactose, Maltodextrin, FD&C Yellow No. 6, FD&C Green No. 3

Image

image of packaging

COLD REMEDY SOOTHING 
chlorpheniramine maleate, acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE1.05 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN105 mg
Inactive Ingredients
Ingredient NameStrength
LONICERA CONFUSA WHOLE (UNII: 22L2C7GWOA)  
FORSYTHIA SUSPENSA WHOLE (UNII: RO2K2K561Z)  
SCHIZONEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)  
SOYBEAN (UNII: L7HT8F1ZOD)  
LOPHATHERUM GRACILE LEAF (UNII: R417138GE9)  
ARCTIUM LAPPA FRUIT (UNII: EA541308MV)  
PHRAGMITES AUSTRALIS ROOT (UNII: BBJ7AOM815)  
PLATYCODON GRANDIFLORUM ROOT (UNII: 2DF0NS0O2Z)  
GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
BETADEX (UNII: JV039JZZ3A)  
LACTOSE (UNII: J2B2A4N98G)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Product Characteristics
ColorgreenScoreno score
ShapeROUNDSize11mm
FlavorLICORICEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51367-002-1212 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/24/1987
Labeler - International Nature Nutraceuticals (006106879)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Dezhong Pharmaceutical Co. Ltd529754442manufacture(51367-002)

Revised: 8/2012
Document Id: b585ed68-598a-4953-a527-fb63ae7d1dfe
Set id: 0e0577fd-e7f7-4772-afce-4e935641b528
Version: 1
Effective Time: 20120801
 
International Nature Nutraceuticals