COLD REMEDY SOOTHING- chlorpheniramine maleate, acetaminophen tablet

Cold Remedy Soothing by

Drug Labeling and Warnings

Cold Remedy Soothing by is a Otc medication manufactured, distributed, or labeled by International Nature Nutraceuticals, Foshan Dezhong Pharmaceutical Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

COLD REMEDY SOOTHING 
chlorpheniramine maleate, acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51367-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE	1.05 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	105 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score	no score
Shape	ROUND	Size	11mm
Flavor	LICORICE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51367-002-12	12 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/24/1987

Labeler - International Nature Nutraceuticals (006106879)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Dezhong Pharmaceutical Co. Ltd		529754442	manufacture(51367-002)