Cold Remedy Soothing

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 1.05mg, ACETAMINOPHEN 105mg
Labeler: International Nature Nutraceuticals
NDC Code: 51367-002

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.

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:

  • Fever
  • Itiching of the nose or throat
  • Minor aches and pains
  • Sneezing
  • Muscle aches
  • Headache
  • Runny nose
  • Itchy eyes

Warnings

Do Not Use:

  • Pain lasts more than 10 days
  • Fever lasts more than 3 days
  • If pregnant or breast-feeding, ask a health professional before using

Ask a doctor or pharmacist before use if you are
  • Taking other medications
  • Have glaucomea
  • A breathing problem such as emphysema or chronic bronchitis
  • Difficulty in urination due to enlargement of the prostate gland

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
  • Condition worsens
  • Symptoms persit for more than 7 days
  • Symptoms clear up and occur again within a few days

Directions

Adults and children 12 years of age and older

  • Take 2 tablets every 4 hours, not to exceed more than 12 tablets in 24 hours

Children ages 6 to 12 years old

  • Take 1 tablet every 4 hours, not to exceed more than 6 tablets in 24 hours

Children under 6 years of age

  • Consult a doctor

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

COLD REMEDY SOOTHING 
chlorpheniramine maleate, acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51367-002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE1.05 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN105 mg
Inactive Ingredients
Ingredient NameStrength
LONICERA CONFUSA WHOLE 
FORSYTHIA SUSPENSA WHOLE 
SCHIZONEPETA TENUIFOLIA FLOWERING TOP 
SOYBEAN 
LOPHATHERUM GRACILE LEAF 
ARCTIUM LAPPA FRUIT 
PHRAGMITES AUSTRALIS ROOT 
PLATYCODON GRANDIFLORUM ROOT 
GLYCYRRHIZA URALENSIS 
ASCORBIC ACID 
PEPPERMINT OIL 
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
BETADEX 
LACTOSE 
MALTODEXTRIN 
FD&C YELLOW NO. 6 
FD&C GREEN NO. 3 
Product Characteristics
ColorgreenScoreno score
ShapeROUNDSize11mm
FlavorLICORICEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51367-002-1212 TABLET 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/FEIOperations
Foshan Dezhong Pharmaceutical Co. Ltd529754442manufacture(51367-002)

Revised: 08/2012
 
International Nature Nutraceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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