COUGH AND SORE THROAT NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Cough and Sore Throat Nighttime by

Drug Labeling and Warnings

Cough and Sore Throat Nighttime by is a Otc medication manufactured, distributed, or labeled by Kinray LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 15 mL tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Purpose

Pain reliever / Fever reducer

Cough suppressant

Antihistamine

Uses

• sore throat
• headache
• minor aches and pains
• fever
• runny nose and sneezing, cough

Warnings

Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Acetaminophen or oter pain releivers/ fever reducers.

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 of this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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.
• to make a child sleep
• if you are allergic to acetaminophen or any of the ingredients in this product.

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• 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
• alcohol, sedatives and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when operating machinery

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 recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 recommended - see overdose warning
• use dose cup or Tabelspoon (TBSP) every 6 hours as needed
• do not exceed 4 doses in 24-hour period

• Adults and children 12 years of ageand over:
  • take 2 tablespoons (tbsp) 30 ml in dose cup provided every 6 hours as needed
• Children under 12 years:
  • do not use this product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

• Store at room temperature 15°- 30°C (59° - 86°F)
• Protect from freezing
• each tablespoon contains: sodium 21 mg

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive ingredients

carboxy methyl cellulose sodium, citric acid, FD&C Blue #1, flavor, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol and sucrose

Questions or comments?

1-845-692-5799

Principal Display Panel

Cough & Sore Throat

Cough & Sore Throat

INGREDIENTS AND APPEARANCE

COUGH AND SORE THROAT NIGHTTIME 
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-075
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MENTHOL (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	BLUE (clear)	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-075-08	236 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/28/2006

Labeler - Kinray LLC (012574513)