SEVERE COLD AND COUGH RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Severe cold and cough relief by

Drug Labeling and Warnings

Severe cold and cough relief by is a Otc medication manufactured, distributed, or labeled by AAFES/Your Military Exchanges, P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethoprhan HBr 20 mg

Phenlyephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves these symptoms due to a cold
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough due to minor throat and bronchial irritation
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allery alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away

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 non-prescription). 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.

Ask a doctor before use if the user has

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product,

do not exceed recommended dosage.

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occurs 
• pain, nasal congestion 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)
• do not exceed 6 doses in any 24 hour period
• measure only with dosing cup provided. Do not use any other dosing device.
• mL=milliliter
• keep dosing cup with product
• adults and children 12 years and over: 30 mL every 4 hours
• children under 12 years of age: do not use

Other information

• each 30 mL contains: sodium 16 mg
• store between 20-25ºC (68-77ºF)
• do not refrigerate

Inactive ingredients

acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C Blue# 1, FD&C Red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate.

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to the active ingredients in Theraflu® Daytime Severe cold & cough*

Severe cold and cough relief

Daytime

Acetaminophen 650 mg/ Pain reliever/ fever reducer

Dextromethorphan HBr 20 mg/ Cough Suppressant

Phenylephrine HCl 10 mg/ Nasal Decongestant

cough

nasal congestion

aches, fever & sore throat

Manufactured for your Military Exchanges

By: PL Developments, 11865 S. Alameda st., Lynwood, CA 90262

8.3 fl oz (245 mL)

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Theraflu® Daytime severe cold and cough

Package Label

Severe cold and cough relief

INGREDIENTS AND APPEARANCE

SEVERE COLD AND COUGH RELIEF 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-316
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10  mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55301-316-08	245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/16/2015	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/16/2015	12/31/2020

Labeler - AAFES/Your Military Exchanges (001695568)

Registrant - P & L Development, LLC (079765031)